Product Quality Engineer Salary in Connecticut, USA

The Quality Engineer in this role will:Maintain ISO 9001 Quality Management System (QMS) records, ensuring smooth operation and accurate documentation.Conduct and coordinate regular audits within the ISO department, and also contribute to recertifications.Collaborate crossfunctionally to promote process improvements.Ensure compliance of product lines and processes.Identify and investigate non-conformances through Quality Activities.Create Documentation and tracking metrics to ensure process improvements and adherence to guidelinesAnalyze process capability, using statistical methods to interpret in-process and final inspection results.Evaluate and implement strategies to reduce waste.Take on additional responsibilities as needed or as required by the position.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The successful Quality Engineer has:Understanding of Geometric Dimensioning and Tolerancing (GD&T), blueprint interpretation, and the ability to conduct dimensional inspections.Experience with metrology and Coordinate Measuring Machine (CMM) operation/programming is a strong plus.A Bachelor's degree in Quality, Industrial, or Mechanical Engineering is preferred.A minimum of 2 years of experience in quality engineering, quality assurance, or a related field.Excellent analytical and problem-solving skills are essential.

Triumph GroupBusiness Overview Location: West Hartford, CT, US, 06110-1328Business Unit: Systems and SupportFunction: Engineering (Quality) About UsTriumph Group designs, engineers, manufactures, repairs, and overhauls a broad portfolio of aviation and industrial components, accessories, subassemblies, systems, and aircraft structures. We partner with original equipment manufacturers (OEMs) and operators of commercial, regional, business, and military aircraft worldwide, to provide products and services that solve their hardest problems. So, whatever the part, component or complexity of assembly, Triumph is committed to quality, service and meeting the specialized needs of each customer. Triumph participates at all levels of the aerospace supply chain – from single components to complex systems, to aerospace structures and their contents. We provide solutions for the entire product life cycle of an aircraft – from raw material to aftermarket service. Our unique ability to integrate a broad range of products and capabilities is our competitive advantage. Based in West Hartford CT, Triumph Systems, Electronics and Controls is a leading independent aerospace system supplier for the commercial and military helicopter and business jet markets and employs approximately 500 employees. The Company's key products and services include electronic engine controls, fuel metering units, main fuel pumps and environmental control systems for both the OE and aftermarket/spares end markets. We are rapidly growing and looking for people who feel rewarded by innovation, career growth, and making an impact and while working with state-of-the-art equipment on cutting-edge projects. If you're ready to be challenged, inspired, and supported as you pursue your professional best, we hope you'll explore a future with TRIUMPH.PositionTriumph SEC is seeking an experienced Quality Systems and Compliance Manager that will execute the key elements of Quality Compliance operational plans and lead the quality system audit programs. In addition, you will be a key member in implementing the changes and processes that will ensure continued Quality Compliance. You will also have direct communication and interaction with senior leadership at various levels and locations. Responsibilities•Manage the internal and external Quality Audit program.•Manage the Corrective Action System and document control.•Manage changes, reviews, and releases of procedures and that impact the quality management system throughout the organization, ensuring compliance with internal and external standards.•Organize and tracking 1st and 2nd party audit activities. This includes internal auditor training, certification, pre-audits, co-development of corrective actions, and post audit follow-ups and effectiveness reviews.•Provide guidance on, and explanations of, policies, government regulations, and agency guidelines to ensure compliance with external standards.•Responsible for ensuring compliance to the Quality Management System (QMS) and internal audit program.•Drive standardization of Quality Management System and standard work and ensure quality systems and processes are established, maintained, and improved upon.•Recommend corrective actions and participate/lead root cause analysis investigations.•Manage corrective action system for audit findings.•Interface with and assist the Quality Manager, Quality Engineers, and Inspectors in establishing, implementing, and enforcing quality requirements.•Work with suppliers, customers, and regulatory representatives regarding quality requirements as needed.•Create presentations and communicate/present to internal/external senior level leadership.QualificationsBasic Qualifications:•Typically requires bachelor's degree in science, Technology, Engineering or Mathematics (STEM), or any related degree program.•Minimum of 5 years leadership in Quality, Engineering or Operations with working experience in a engineering development, material and service acquisition, production, test, product acceptance and/or post-delivery support capacity.•Internal audit working experience with AS9100D standards.•Successfully completed certified auditor training•Working experience with Quality Management Systems (QMS).•Working experience with root cause and corrective action (RCCA), 8D, methodology, systems, and resources. Preferred Qualifications: •Proven track record of internal and external audit programs.•Knowledge of Continuous Improvement Tools.•Experience in predictive and proactive measures and metrics assessments and leading actions to improve performance or mitigate problems.•Aerospace Industry experience.•NADCAP Audit certification experience.•Continuous Improvement, LEAN, CORE, ACE, or Six-Sigma training.•Experience with factory ERP/MES systems and software (e.g. PRISM, JDE, Windchill).•Strong written and verbal presentation skills.•Proficiency in Microsoft Office Word, Excel, and PowerPoint.•Collaborative; high performance teams, communication, and problem-solving skills.Benefits•Comprehensive medical, dental and vision coverage with plan options that provide flexibility and choice (including telehealth options)•Healthcare spending accounts•Paid parental leave•Paid/flexible time off in addition to paid company holidays•401(k) with company match•Employee Stock Purchase Plan•Disability and life insurance•Incentives and performance-based rewards•Exciting growth and development opportunities empowered by our TRIUMPH Transformation and an entrepreneurial environment that encourages innovation and creativityVision and MissionOur Vision:As one team, we enable the safety and prosperity of the world. Our Mission:We partner with our Customers to TRIUMPH over their hardest aerospace, defense, and industrial challenges to deliver value to our stakeholders. Our Values:1.Integrity – Do the right thing for our stakeholders. We value safety, diversity, and respect.2.Teamwork – Win as One team-one company. Solicit help and assist others.3.Continuous Improvement – Pursue zero defect quality. Attack problems and relentlessly raise the bar.4.Innovation – Passion for growing the business. Lead through ingenuity and entrepreneurship.5.Act with Velocity – Partner, anticipate and communicate. Proactively solve problems.Physical Demands The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, talk, or hear. The employee frequently is required to stand, walk, and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms: stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 30 pounds.EHSEmployees are responsible for the Health, Safety, and Welfare of themselves, the environment, and other people. All employees must comply with EHS policy training and instructions, help to maintain a safe and clean working environment, and use any Personal Protective Equipment (PPE) provided by the Company. Employees must report any accidents, incidents, and near misses to management. Additionally, employees are expected to notify management of any dangerous or potentially dangerous situations or practices. Code of ConductTo perform the job successfully, an individual should demonstrate the TRIUMPH behaviors captured within our core values: Integrity, Teamwork, Continuous Improvement, Innovation, and Act with Velocity. Detailed definitions are below and performance metrics for each behavior can be found on our intranet and is embedded within our Performance Management processes. All employees are expected to represent the values and maintain the standards contained in TRIUMPH's Code of Conduct. Pursuant to International Traffic Arms Regulations (ITAR) and the Export Administration Regulations (EAR), applicants for SELECT positions will be required to provide proof of U.S. Citizenship, U.S. Permanent Residence, or U.S. Immigration Status in order to meet the minimum qualifications for those select positions. All inquiries related to citizenship are asked solely to comply with ITAR and EAR export licensing requirements. Legally authorized to work in the United States without company sponsorship. Triumph Group and all its divisions and subsidiaries are Equal Opportunity/Affirmative Action Employers. Triumph Group provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should [email protected] request assistance. Include the title of the position and location in the subject line of your email so we may direct your email to the appropriate person. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to."An Equal Opportunity Employer - Minorities/Females/Disabled/Veterans" We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other characteristic protected by law. Pursuant to International Traffic Arms Regulations (ITAR) and the Export Administration Regulations (EAR), applicants for SELECT positions will be required to provide proof of U.S. Citizenship, U.S. Permanent Residence, or U.S. Immigration Status in order to meet the minimum qualifications for those select positions. All inquiries related to citizenship are asked solely to comply with ITAR and EAR export licensing requirements.The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c).PI241179011

Careers that Change Lives Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results...the right way. That's the Medtronic Mindset - our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.The Principal Quality Engineer is an individual contributor with responsibility in supporting R&D laboratories in technical functions to advance existing technology or introduce new technology and therapies. This position will partner with laboratories across a global network to drive a quality culture and improvements in day-to-day activities. The Principal Quality Engineer will be a role model and mentor for others on the quality team and work closely with laboratory management to drive change. The position will formulate, deliver and/or manage projects assigned and work with other stakeholders to achieve desired results.A Day in the LifeResponsibilities may include the following and other duties may be assigned. Collaborate with laboratories globally in network to ensure quality standards are in place. Support and champion parts of strategy development and execution. Collaborate with other quality groups across Medtronic. Ensure that corrective measures meet acceptable standards, and that documentation is compliant with requirements. Lead laboratory investigations, root cause analysis and nonconformance reports. Perform audits and provide audit support. Approval of protocols, reports, and testing results. Identify and lead continuous improvement activities in quality processes. Coach, mentor, and review work of lower-level quality engineers and specialists. Must Have: Minimum Requirements Bachelor's degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality Nice to Have Bachelor's or master's degree in chemistry, biotechnology or related field Previous experience in the pharma industry is preferred. CQA and CQE certification is preferred. Knowledge of ISO 17025 Knowledge of ISO 10993 and 21 CFR part 58 is preferred. Previous quality management system experience including root cause analysis, non-conformances and CAPA. Previous experience with internal and external audits as well as conducting internal audits. Ability to work independently under limited supervision to determine and develop approach to solutions. Experience managing projects / processes, as well as coaching and reviewing the work of lower-level specialists. Ability to work collaboratively, exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Recognized expert managing large projects or processes. Adaptability and ability to navigate through change. About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Principal ResponsibilitiesProvide technical support to the Sales force in the areas of bearing design, design improvements, customer support, production support and review of new applications. Works with customers to resolve technical problems and makes technical presentations with the Sales Engineers at target accounts. Review of new applications and provide technical solutions to ensure product performance. Responsible for the conceptual design engineering of new products, special products and contribute to the improvement of existing products and manufacturing methods to meet customer demands. Technical consultant on product design, application and service problems, quality deviations and material and parts substitution. Assists in the technical education of sales trainees and personnel of other departments. Member of the Material Review Board which is responsible for the disposition of all nonconforming product and materials. Functions as an engineering consultant to manufacturing on problems related to the manufacture of the company's products. Provides product design requirements to mechanical designers assigned to specific projects and assures that all detail drawings are in conformance to the requirements and technical specifications. Responsible for establishing new products into the MRP system and creating the associated Bill-of-Material. Responsible for approving new product designs and releasing designs to manufacturing Supports lean enterprise activities.

Triumph GroupBusiness OverviewLocation: West Hartford, CT, US, 06110-1328Business Unit: Systems and SupportFunction: Engineering (Quality) About UsTriumph Group designs, engineers, manufactures, repairs, and overhauls a broad portfolio of aviation and industrial components, accessories, subassemblies, systems, and aircraft structures. We partner with original equipment manufacturers (OEMs) and operators of commercial, regional, business, and military aircraft worldwide, to provide products and services that solve their hardest problems. So, whatever the part, component or complexity of assembly, Triumph is committed to quality, service and meeting the specialized needs of each customer. Triumph participates at all levels of the aerospace supply chain – from single components to complex systems, to aerospace structures and their contents. We provide solutions for the entire product life cycle of an aircraft – from raw material to aftermarket service. Our unique ability to integrate a broad range of products and capabilities is our competitive advantage. Based in West Hartford CT, Triumph Systems, Electronics and Controls is a leading independent aerospace system supplier for the commercial and military helicopter and business jet markets and employs approximately 500 employees. The Company's key products and services include electronic engine controls, fuel metering units, main fuel pumps and environmental control systems for both the OE and aftermarket/spares end markets. We are rapidly growing and looking for people who feel rewarded by innovation, career growth, and making an impact and while working with state-of-the-art equipment on cutting-edge projects. If you're ready to be challenged, inspired, and supported as you pursue your professional best, we hope you'll explore a future with TRIUMPH.PositionWe have an exciting opportunity for a Quality Assurance Engineer to join our West Hartford, CT team. In this role, you will provide quality assurance engineering support to internal and external customers and all departments within the organization. This position will be instrumental in implementing the Quality Assurance strategy of the company to ensure continuous flow of products consistent with established industry standards, government regulations, and customer requirements. Responsibilities•Develop and analyze statistical and product/process performance data to recommend and implement improvements in the Hydromechanical value stream. Provide Quality support with the objective of improving process performance and capability.•Execute the initiatives of the organization in the development, implementation, and improvement of the appropriate Quality Management Systems throughout the operation with all the documentation required. This includes providing advanced quality planning support in the development and launch of new products, processes, and services, along with continuous improvement of existing product lines.•Provide Quality interface and expertise between the organization and its customers to proactively assure that needs and expectations are understood and satisfied. This includes contract review/flow down, the compliance management process, and the implementation of corresponding corrective/preventive actions.•Provide expertise in Quality Assurance and process improvement tools and methods to support continuous improvement activities.•Develop, implement, and audit inspection and test plans, standards and acceptance criteria, and procedures/work instructions. Facilitate the investigation and elimination of quality problems and follow-up on corrective actions. •Participate in all aspects of product development and launch activities. Efforts in this area include the identification of customer expectations, manufacturing and test support requirements, design reviews, evaluation of test programs, development of inspection requirements, and management of costs.Qualifications•Bachelor's degree in Engineering, Science, Technology, Quality or another related technical field preferred.•5+ years of experience in a Quality role within a complex manufacturing environment. •Aerospace and applicable regulatory authority knowledge/experience desired. •Must have thorough understanding of problem-solving methods, i.e., 8D, root cause analysis, etc., and the associated statistical tools used to analyze problems.•Knowledge of effective new product development and launch system. Strong knowledge of the associated tools such as PFMEA, Control Plans, Characteristic Matrix, Gage Capability, Process Capability, Process Flow, Preventive Maintenance, etc. •Understanding of standards, implementation, and certification process of Quality Management Systems such as AS9100, ISO-9001, AS13100 or any other industry-specific standard or regulation.•Capable of preparing and approving First Article Inspection Reports per AS9102 and presenting same to customers. •Ability to interface effectively with all departments and levels of the Triumph organization as well as with external customers.•Excellent verbal and written communication skills.•MS Office suite experience required, including expertise in PowerPoint, Excel, and Word•Ability and willingness to travel approximately 20% •Familiarity with InspectionXpert, Net-Inspect, Minitab, JDE and Teamcenter Benefits•Comprehensive medical, dental and vision coverage with plan options that provide flexibility and choice (including telehealth options)•Healthcare spending accounts•Paid parental leave•Paid/flexible time off in addition to paid company holidays•401(k) with company match•Employee Stock Purchase Plan•Disability and life insurance•Incentives and performance-based rewards•Exciting growth and development opportunities empowered by our TRIUMPH Transformation and an entrepreneurial environment that encourages innovation and creativityVision and MissionOur Vision:As one team, we enable the safety and prosperity of the world. Our Mission:We partner with our Customers to TRIUMPH over their hardest aerospace, defense, and industrial challenges to deliver value to our stakeholders. Our Values:1.Integrity – Do the right thing for our stakeholders. We value safety, diversity, and respect.2.Teamwork – Win as One team-one company. Solicit help and assist others.3.Continuous Improvement – Pursue zero defect quality. Attack problems and relentlessly raise the bar.4.Innovation – Passion for growing the business. Lead through ingenuity and entrepreneurship.5.Act with Velocity – Partner, anticipate and communicate. Proactively solve problems.Physical DemandsThe work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, talk, or hear. The employee frequently is required to stand, walk, and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms: stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 30 pounds.EHSEmployees are responsible for the Health, Safety, and Welfare of themselves, the environment, and other people. All employees must comply with EHS policy training and instructions, help to maintain a safe and clean working environment, and use any Personal Protective Equipment (PPE) provided by the Company. Employees must report any accidents, incidents, and near misses to management. Additionally, employees are expected to notify management of any dangerous or potentially dangerous situations or practices.Code of Conduct To perform the job successfully, an individual should demonstrate the TRIUMPH behaviors captured within our core values: Integrity, Teamwork, Continuous Improvement, Innovation, and Act with Velocity. Detailed definitions are below and performance metrics for each behavior can be found on our intranet and is embedded within our Performance Management processes. All employees are expected to represent the values and maintain the standards contained in TRIUMPH's Code of Conduct. Pursuant to International Traffic Arms Regulations (ITAR) and the Export Administration Regulations (EAR), applicants for SELECT positions will be required to provide proof of U.S. Citizenship, U.S. Permanent Residence, or U.S. Immigration Status in order to meet the minimum qualifications for those select positions. All inquiries related to citizenship are asked solely to comply with ITAR and EAR export licensing requirements. Legally authorized to work in the United States without company sponsorship. Triumph Group and all its divisions and subsidiaries are Equal Opportunity/Affirmative Action Employers. Triumph Group provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should [email protected] request assistance. Include the title of the position and location in the subject line of your email so we may direct your email to the appropriate person. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to."An Equal Opportunity Employer - Minorities/Females/Disabled/Veterans" We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other characteristic protected by law. Pursuant to International Traffic Arms Regulations (ITAR) and the Export Administration Regulations (EAR), applicants for SELECT positions will be required to provide proof of U.S. Citizenship, U.S. Permanent Residence, or U.S. Immigration Status in order to meet the minimum qualifications for those select positions. All inquiries related to citizenship are asked solely to comply with ITAR and EAR export licensing requirements.The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c).PI241630829

POSITION SUMMARYA highly-motivated, goal-focused, mid-tier Quality Engineer accountable for adherence to project-related internal quality processes, quality of supplied systems/parts including non-conforming incoming material review and resulting root cause analyses, corrective action and disposition, as well as outgoing product quality.Responsible for generating, organizing and communicating all Quality-related documentation required CORE RESPONSIBILITIESCoordinate with multi-functional team members to successfully adhere to the quality Plan.Support (Lead if needed) efforts to determine Root Cause and required Corrective Actions to resolve supplier and internal Quality-related issues. Drive required documentation and resolution.Lead coordination of required part inspection, FAI generation & approval (or needed follow-up & resolution) & filing of reports as required.Collaborate and actively Participate with Material Review Board & MRB Coordinator > drive timely processing and resolution of MINIMUM: 4 years in an engineering role which included quality, and/or supplier/commodity engineering.Familiar with Quality Management Systems.Good organizational, time management, documentation and communication skills.Familiar with creating and managing quality metrics and reporting thereof.Communicate effectively with peers & management and provide innovative thinking to resolve issues.Maintain professional conduct & positive working relationships with all multi-functional peers & management.PREFERRED:Prior experience with Material Review Board practices/processes - leading or participating.Certified Quality Professional - ASQ or other.Prior experience in the mailing equipment industry.

Schneider Electric is seeking several Supplier Quality Engineers to support our North American Operations. This can be a hybrid schedule: 2 days/week onsite and 3 days/week remote. Travel can be up to 40%, mostly to local US based suppliers.Come be a part of our substantial growth, where we are adding to our supplier base, increasing capacity, and continually improving our processes. You will have the opportunity to be engrained in our company in a high visibility position while being well connected to our global supply chain. The main focus initially will be in coordinating and managing supplier quality standards and policies, with an emphasis on PPAP.What will you do?o Identifying, coaching, and managing suppliers according to organization quality standards and policies o Management of PPAP for key projects including duplicate supply, tooling moves and outsourcing activities.o Analyzing quality processes of suppliers (PFMEA, Process Control Plans, MSA, capability studies)o Providing advice and training on quality protocols and conducting audits to ensure compliance with organization and applicable government standards o Resolving supplier problems related to quality, performance, and service level o Identifying and certifying alternative suppliers to mitigate supply disruption risks with the support of the US Services Sourcingo Deploy / set-up at Supplier the Quality referential as per SSQM process (performance measurement referential, PPAP, 8D, etc.).o Directly manage most complex/critical Supply/Supplier issues escalated.o tracking of supply chain upstream parameters (Lead Time, Order Quantity, stock, forecast)o Schneider Electric specific Upstream tools and data base usageo Coordinating and working with suppliers on any applicable plant rejectionso Coordinating with quality department for appropriate feedbacko Working with engineering on any PPAP related quality items and services to ensure we follow the supplier quality standardsWhat qualifications will make you successful? • Bachelor's Degree in Engineering or related field • 5+ years of professional experience in supplier quality or quality function• Manufacturing process knowledge, mainly for mechanical components• Good knowledge of QMS, PPAP, Problem solving tools, Auditing• Expertise in using MS office (Particularly excel extract, pivot table etc)• Strong Communication and ability to influence skills• Able to work in matrix organization• Eager to learn, adapt and be flexibleWhat's in it for me? Schneider Electric offers a robust benefits package to support our employees such as flexible work arrangements, paid family leave, 401(k)+ match, and more. Click here to find out more about working with us: http://se.com/us/careers .We seek out and reward people for putting the customer first, being disruptive to the status quo, embracing different perspectives, continuously learning, and acting like owners. We're recognized around the world for welcoming people as they are. We create an inclusive culture where all forms of diversity are seen as a real value for the company. See what our people have to say about working for Schneider Electric. https://youtu.be/C7sogZ_oQYgWho will you report to?Supplier Quality Manager Let us learn about you! Apply today. You must submit an online application to be considered for any position with us. This position will be posted until filled. #LI-MC5 Why us?At Schneider Electric we're committed to creating a workplace that gives you not just a job but a meaningful purpose in joining our mission to bring energy and efficiency to enable life, progress and sustainability for all.We believe in e mpowering our team members to reach their full potential, fostering a sense of ownership in their work.We embrace inclusion as a fundamental value, ensuring that every voice is heard and valued. We value differences, and welcome people from all walks of life. We believe in equal opportunities for everyone, everywhere.If you want to be part of a company where your contributions truly matter, where you are empowered to make a difference and where inclusivity is valued, we would love to hear from you.Discover your M eaningful, Inclusive and Empowered career at Schneider Electric.€34.2bn global revenue +12% organic growth 135 000+ employees in 100+ countries #1 on the Global 100 World's most sustainable corporationsYou must submit an online application to be considered for any position with us. This position will be posted until filledSchneider Electric aspires to be the most inclusive and caring company in the world, by providing equitable opportunities to everyone, everywhere, and ensuring all employees feel uniquely valued and safe to contribute their best.We mirror the diversity of the communities in which we operate and we 'embrace different' as one of our core values. We believe our differences make us stronger as a company and as individuals and we are committed to championing inclusivity in everything we do. This extends to our Candidates and is embedded in our Hiring Practices.You can find out more about our commitment to Diversity, Equity and Inclusion here and our DEI Policy hereSchneider Electric is an Equal Opportunity Employer. It is our policy to provide equal employment and advancement opportunities in the areas of recruiting, hiring, training, transferring, and promoting all qualified individuals regardless of race, religion, color , gender, disability, national origin, ancestry, age, military status, sexual orientation, marital status, or any other legally protected characteristic or conduct.Schneider Electric is seeking several Supplier Quality Engineers to support our North American Operations. This can be a hybrid schedule: 2 days/week onsite and 3 days/week remote. Travel can be up to 40%, mostly to local US based suppliers.Come be a part of our substantial growth, where we are adding to our supplier base, increasing capacity, and continually improving our processes. You will have the opportunity to be engrained in our company in a high visibility position while being well connected to our global supply chain. The main focus initially will be in coordinating and managing supplier quality standards and policies, with an emphasis on PPAP.What will you do?o Identifying, coaching, and managing suppliers according to organization quality standards and policies o Management of PPAP for key projects including duplicate supply, tooling moves and outsourcing activities.o Analyzing quality processes of suppliers (PFMEA, Process Control Plans, MSA, capability studies)o Providing advice and training on quality protocols and conducting audits to ensure compliance with organization and applicable government standards o Resolving supplier problems related to quality, performance, and service level o Identifying and certifying alternative suppliers to mitigate supply disruption risks with the support of the US Services Sourcingo Deploy / set-up at Supplier the Quality referential as per SSQM process (performance measurement referential, PPAP, 8D, etc.).o Directly manage most complex/critical Supply/Supplier issues escalated.o tracking of supply chain upstream parameters (Lead Time, Order Quantity, stock, forecast)o Schneider Electric specific Upstream tools and data base usageo Coordinating and working with suppliers on any applicable plant rejectionso Coordinating with quality department for appropriate feedbacko Working with engineering on any PPAP related quality items and services to ensure we follow the supplier quality standardsWhat qualifications will make you successful? • Bachelor's Degree in Engineering or related field • 5+ years of professional experience in supplier quality or quality function• Manufacturing process knowledge, mainly for mechanical components• Good knowledge of QMS, PPAP, Problem solving tools, Auditing• Expertise in using MS office (Particularly excel extract, pivot table etc)• Strong Communication and ability to influence skills• Able to work in matrix organization• Eager to learn, adapt and be flexible

This is what you will do: This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.You will be responsible for: Own the design and implement studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sitesLead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal directionPrioritizing multiple tasks and projects independently and as part of the teamAuthor SOPs, study protocols and technical reportsParticipate in multi-functional development teams representing Injectable Drug Product DevelopmentMaintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertiseActively participate in department and team meetings including assuming ownership and delivering on assign action itemsDevelop presentations for meetings with internal and external partnersYou will need to have:Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master's degree with 3+ years of relevant work experienceDedicated initiative to find resolution for technical challengesExcellent interpersonal, collaborative and communication skillsThe duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Scientific and practical knowledge of protein biochemistry and/or drug product process developmentPrevious experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLAScientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plusHigh level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointExpectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do: This position will lead research, design and implement scientific studies to enable the drug product (DP) process development, characterization, clinical manufacturing, and commercial validation of parenteral/injectable biologic products. Lead and support execution of stability studies, data processing, compiling and presentation of results supporting late-stage clinical activities as well as preparation for PPQ. Develop a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. A general understanding of protein chemistry and/or the ability to run biopharmaceutical assays in a laboratory is preferred.The role will lead manufacturing technology transfer activities in preparation for DS and DP PPQs, sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as leading at-scale/full scale process development studies, and authoring protocols, and reports. In addition, will support deviation investigations, change controls, and CAPAs using electronic Quality system. The candidate will also provide clinical and commercial manufacturing site support including but not limited to periodic meetings, action item owner, and in-person on-site manufacturing support. Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.You will be responsible for: Own the design and implement studies for Alexion pharmaceuticals' clinical drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sitesLead progression of projects with multi-functional collaborators, as well as understand the implications of project activities and decisions with minimal directionPrioritizing multiple tasks and projects independently and as part of the teamAuthor SOPs, study protocols and technical reportsParticipate in multi-functional development teams representing Injectable Drug Product DevelopmentMaintain knowledge of current trends in drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations and scientific principles and theories. Train other peers as assigned in areas of expertiseActively participate in department and team meetings including assuming ownership and delivering on assign action itemsDevelop presentations for meetings with internal and external partnersYou will need to have:Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 4+ years of relevant experience or Master's degree with 3+ years of relevant work experienceDedicated initiative to find resolution for technical challengesExcellent interpersonal, collaborative and communication skillsThe duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Scientific and practical knowledge of protein biochemistry and/or drug product process developmentPrevious experience in bio-therapeutics development as well as relevant knowledge of cGMP and Quality expectations for PPQs and BLAScientific understanding of protein stability, thermodynamics, mechanism of protein degradation, bio-therapeutics drug formulation development and analytical tools used to test formulations is a plusHigh level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointExpectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world!Date Posted26-Apr-2024Closing Date30-Jul-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Careers that Change LivesIn this exciting role as a Principal Post-Market Quality Engineer you will have responsibility for developing and implementing best practices in risk management and for providing risk management expertise throughout the product life cycle including development, market release, and post-market activities within the Robotics Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware.A Day in the LifeProvide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management.Responsibilities may include the following and other duties may be assigned.Responsibilities may include the following and other duties may be assigned. Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase. Conduct health hazard assessments or IIAs for fielded products. Conduct Corrections & Removals assessments. Collaborate cross functionally to perform bounding/scoping for field actions and assist in field action related regulatory inquiries. Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes, Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence. Support Complaint trending and Severity trending signal dispositions. Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation. Actively communicate findings to Quality, Development, and Operations teams and escalates when the risk profile of a medical device adversely changes. Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings. Develops, modifies, applies and maintains quality standards and protocol for risk management. Makes decisions and proposes solutions based on calculated risks identified through data analysis Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines. Capable of leading cross-functional projects with little or no guidance. Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities. Participate in meeting departmental goals and objectives. Mentor or supervise junior engineers. Must Have: Minimum Requirements Bachelors degree required Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience Must Have: Minimum Requirements Bachelors degree required Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience Nice to Have Working knowledge of medical device products Excellent communication and technical writing skills Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies to understand and quantify residual risks. Six-Sigma greenbelt or blackbelt certification Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here . This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here . The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc. About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)