Product Quality Engineer Salary in Danvers, MA

As a Quality Engineer in our Danvers, MA, production site, you play a key role in the success of the Quality and Manufacturing organizations. Key responsibilities include but are not limited to:Utilize root cause analysis tools to complete product and process related investigations.Lead and support risk assessments utilizing FMEA.Review and improve standard operating procedures and other production documentation.Support customer-facing improvement projects that incorporate evolving customer and industry requirements.Conduct internal GMP and ISO audits.Support deviation resolution in production and corrective action implementationAssures products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP, and MilliporeSigma standards.Monitor and trend process performance and drive continuous improvement.Lead projects with cross functional teams to improve in-process quality, reduce customer complaints, and increase production efficiency. Who You Are: Minimum qualifications: Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or other Engineering discipline OR Biology, Chemistry, or other Life Science discipline. Preferred Qualifications: 1+ years of experience in Biotechnology, Pharmaceutical, Medical Device, or Life Science industries.Lean Six Sigma and/or root cause analysis training.Experience leading risk assessments using tools such as FMEA.Experience with Quality Systems. (e.g. Deviation, CAPA, Change Control, Documentation Management)Experience conducting internal/customer/supplier audits.Demonstrated ability to write and execute test protocols and reports.CQA or CQE. RSREMDDemonstrate strong quality knowledge: GMP/GDP, ISO standards. RSREMDRSREMD RSREMD

Careers that Change LivesA career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.In this exciting role as a Quality Engineer II, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. This is an onsite role at the Danvers, MA location. A Day in the Life Responsibilities may include the following and other duties may be assigned. Provide Quality Engineering support for commercial medical device products. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Present technical data to groups within and outside the organization. Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings. Must Have: Minimum Requirements Bachelor's Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality Nice to Have Medical Device Master's degree Manufacturing Experience Green Belt Six Sigma/DRM Training/Certification ASQ-CQE, CQA, CBA or equivalent certifications SAP QM or SPC Software Experience Effective verbal and written communication, analytical, influencing and interpersonal skills Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 Demonstrated working knowledge of process validation, statistical methods, risk management 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)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) here .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Coordinate the management process for product escapes, identifying root causes and implementing corrective/preventive actions.Facilitate and coach cross-functional Problem Resolution Teams for product escapes and assist in high-impact organizational issues.Maintain cooperative relationships with all departments, customers, and suppliers, leveraging problem-solving interactions across the enterprise.Coordinate, track, and manage RMA processes to completion.Generate, maintain, and provide quality metrics to the management team, overseeing quality improvement programs.Drive continuous improvement initiatives using data and KPIs.Provide technical support and maintain strong working relationships with the operations team.Investigate and analyze hardware/assembly issues affecting quality and delivery, reviewing procedures, specifications, instructions, processes, and equipment to ensure compliance and resolve concerns.Build cross-departmental relations to effectively communicate the status of parts.Process MRB parts under review.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.Expertise in RCCA tools with strong capability in executing robust systemic RCCA.Proficient in interpreting and understanding engineering technical data, including manufacturing and part drawings, to guide cross-functional teams.Extensive experience in managing Quality Management Systems and using MRP/ERP/SAP systems for production control, planning, manufacturing execution, clinic, and MRB.Resilient in handling challenging situations, consistently finding ways to achieve desired outcomes.Proven ability to interface effectively with all management levels, customers, and government agencies.Knowledgeable in aerospace quality standards, including AS9100, AS9102, and ISO.US citizenship required for government contracts.Preferred qualification: Certified 6 Sigma Blackbelt or equivalent.

Reviews documentation related to internal and external manufacturing processes to ensure quality products are delivered to the customer.Utilizes lean initiatives to reduce waste and maintain continuous improvement.Development and execution of Quality Plans for customer accounts.Drive improvement of Quality through analyzing non-conformances and performing root cause analysis of discrepancies.Collect data about instances of product errors and investigate possible solutions by troubleshooting the manufacturing or design process.Apply strong theoretical knowledge of electronics manufacturing engineering principles to identify issues which could or will impact product quality.Propose, review and implement approved corrective and preventive actions.Analyze/modify current product processes and implement improvements.Perform a variety of complex engineering tasks to improve the reliability and manufacturability of products.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.BS in Electrical Engineering or related discipline 3-5+ years of experience working in an electronics manufacturer Demonstrated leadership skills and the ability to drive for resultsFamiliar with Lean Manufacturing PrincipalsWorking knowledge of SPC, Design of Experiments and Gage DesignProven analytical and organizational abilityEffective problem identification and solution skills

Reviews documentation related to internal and external manufacturing processes to ensure quality products are delivered to the customer.Utilizes lean initiatives to reduce waste and maintain continuous improvement.Development and execution of Quality Plans for customer accounts.Drive improvement of Quality through analyzing non-conformances and performing root cause analysis of discrepancies.Collect data about instances of product errors and investigate possible solutions by troubleshooting the manufacturing or design process.Apply strong theoretical knowledge of electronics manufacturing engineering principles to identify issues which could or will impact product quality.Propose, review and implement approved corrective and preventive actions.Analyze/modify current product processes and implement improvements.Perform a variety of complex engineering tasks to improve the reliability and manufacturability of products.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.BS in Engineering 5+ years of experience working in a manufacturing environment Demonstrated leadership skills and the ability to drive for resultsFamiliar with Lean Manufacturing Principals and proficiency in driving robust systemic RCCAKnowledge of aerospace quality standards including AS9100, AS9102, & ISOWorking knowledge of SPC, Design of Experiments and Gage DesignProven analytical and organizational abilityStrong Experience with managing Quality Management Systems and user of MRP/ERP/ SAP systems used in production control, planning, manufacturing execution, clinic and MRB.Effective problem identification and solution skills

In the role of Senior Quality Engineer at our Danvers, MA production site, you hold a pivotal position in the success of the Quality and Manufacturing organizations. Your main responsibilities include:Acting as a steward for product and process quality, offering expertise in the evaluation of change control for Mobius products at Danvers and across various sitesLeading and overseeing product quality investigations in collaboration with R&D, Manufacturing, Validation, and plant engineering, guaranteeing thorough root cause analysis, impact and risk assessment, and the implementation of corrective actionsSupporting process improvement activities with specific focus on right first-time quality metrics, including reduction in non-conformances, reworks, and customer complaintsLeading the execution of Organization Level Agreements, including quality commitments and quality improvement projects, and collaborating with stakeholders and project teams to ensure successful implementationOffering guidance, support, and technical expertise to assist other team members in achieving success Weekday Shift: Monday-Friday Who You Are:Minimum qualificationsAssociate's degree in engineering, applied engineering, sciences or related fieldMinimum of 3 years of relevant and progressive work experience Preferred Qualifications:Bachelor's degree in engineering, applied engineering, sciences, or related fieldStrong people leadership, project management, and problem-solving skills with a proven track record of prioritization and change managementBasic understanding of material analysis tools and techniques i.e., FTIR, DSC Calorimetry, microscopy, particle counters, and integrity testing by pressure decayDetailed understanding of equipment and process validation and qualification in a regulated industry including associated toolkits i.e., p/dFMEA, statistical process control, sampling plansUnderstanding of investigations, impact assessment workflow in a regulated environment subject to time constraints. An understanding of change control process in a regulated industryLean Six Sigma and/or root cause analysis trainingExperience with Quality Systems (e.g., Deviation, CAPA, Change Control, Documentation Management)Proven track record of working collaboratively and communicating successfully in a cross-functional and multi-cultural environmentDemonstrate strong quality knowledge: GMP/GDP, ISO standardsAbility to adapt and thrive in a constantly changing business environmentProficient in computer skills pertaining to MS Word, MS Excel, MS PowerPoint, MS Teams, MS SharePoint to support data review, analysis and sharing

Developing the QMS system as well as the quality control processesWorking alongside other engineers with CMMS, CAPAs, Gage R&R, etcOn the floor experience (manufacturing) Using data to interpret results to there for create new points of actionsCross collaborating with several other engineers on the floorLeading projects to direct non conformancesDrive Continuous Improvement to help with performance initiatives, cost reductions as well as processes with manufacturing and quality documentationMPI 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. Technical Proficiency: A successful candidate should possess a strong understanding of precision engineering principles, quality control techniques, and manufacturing processes.Attention to Detail: Precision and accuracy are paramount in this role, so a keen eye for detail is essential to identify defects or quality issues.Problem-Solving Skills: Successful candidates should be adept at identifying problems, analyzing root causes, and developing effective solutions to improve product quality.Analytical Thinking: Strong analytical skills are required to collect and interpret data, conduct statistical analyses, and make data-driven decisions to enhance quality.Quality Standards Knowledge: A deep understanding of quality standards and certifications relevant to the industry, such as ISO 9001 & AS9100, is crucial for maintaining compliance.Communication Skills: Effective communication, both written and verbal, is essential for collaborating with cross-functional teams, documenting procedures, and presenting findings.Team Player: Quality Engineers often work closely with various departments, so being a collaborative team player is important for success.Continuous Improvement Mindset: A commitment to continuous improvement and a willingness to implement best practices and lean methodologies is highly valued.Problem Prevention Orientation: The ability to proactively identify potential quality issues and implement preventive measures is key to reducing defects.Adaptability: In a dynamic manufacturing environment, adaptability to changing priorities and the ability to work under pressure to meet deadlines are essential qualities.

Assist in development, maintenance and improvement of a quality system.Ensure the document control system for the location complies with the quality systemCreate, review and maintain and track Standard Operating Procedures for complianceImplement best practice test procedures, troubleshooting techniques, root cause analysis, test equipment usage, etc.Define, document, analyze, perform, and interpret tests for products and systemsParticipate in the overall "Quality Effort"Writing quality proceduresWorking with current quality group to pursue different certificationsMPI 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.BS in Engineering disciplineQuality Management System experience is highly desirableExperience with Quality Documentation2-5+ years of experienceExperience in developing testing for digital and/or analog systemsComfortable in a fast paced, quickly changing work environmentAbility to read a variety of testing measuring instrumentsExperience within the lighting industry is highly desirable

Assist in development, maintenance and improvement of a quality system.Ensure the document control system for the location complies with the quality systemCreate, review and maintain and track Standard Operating Procedures for complianceImplement best practice test procedures, troubleshooting techniques, root cause analysis, test equipment usage, etc.Define, document, analyze, perform, and interpret tests for products and systemsParticipate in the overall "Quality Effort"Writing quality proceduresWorking with current quality group to pursue different certificationsMPI 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 Candidate:BS in Engineering disciplineQuality Management System experience is highly desirableExperience with Quality Documentation2-5+ years of experienceExperience in developing testing for digital and/or analog systemsComfortable in a fast paced, quickly changing work environmentAbility to read a variety of testing measuring instrumentsExperience within the lighting industry is highly desirable

Careers that Change LivesA career at Medtronic is like no other. We are looking for a Sr. Supplier Quality Engineer who will be a part of our Global Supplier Quality team. You will be driven by our mission to alleviate pain, restore health and extend life for millions of people worldwide and always 'Put Patient First'.You can grow your career with us; we hope you'll consider joining our team!A Day in the Life Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods Root cause investigation and Supplier CAPA management. Must Have: Minimum Requirements Bachelor's Degree and 4+ years of Supplier Quality Engineering experience OR advanced degree and 2+ years of experience Nice to Have Experience in fast paced environment. Problem solving skills. ASQ CSQP and/or CQE certification. Strong experience working across an organization using written and verbal skills to communicate and understand cross functional teams, interactions and responsibilities. Experience working in an FDA regulated manufacturing environment 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) Travel: Yes, 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) here .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).