Product Engineer Salary in Danvers, MA

Liaison with suppliers: Communicate and address supplier quality issues, customer complaints, CAPA, and improvement opportunities.Managed APCD Global ASL: Oversee the onboarding process, scorecard management, and act as Subject Matter Expert (SME) for supplier processes during internal and external audits.Flexibility: Available to work nonstandard hours or alternate shifts to support operations in North America and Asia.Minitab: Proficient in using Minitab for statistical analysis and process improvement.SPC (Statistical Process Control): Implement and maintain SPC methods to monitor and control manufacturing processes.APQP (Advanced Product Quality Planning): Familiarity with APQP methodologies for new product development and introduction.Supplier Performance Reporting: Generate and present monthly reports on supplier performance.Collaboration: Work closely with Quality Engineering (QE) and First Article Inspection (FAI) teams on FAI processes, and conduct supplier surveys and audits.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 ideal candidate has their Bachelor's Degree in Engineering or a Science discipline or equivalent. Additionally, 2+ years of experience in Quality, Manufacturing and/or Engineering is preferred.Supplier Management: Ability to effectively manage relationships with suppliers, including communication, negotiation, and issue resolution.Process Improvement: Proficiency in identifying inefficiencies in processes and implementing solutions to enhance efficiency and effectiveness.Product Quality: Strong understanding of quality control processes and methodologies to ensure products meet or exceed quality standards.Six Sigma: Familiarity with Six Sigma methodologies and tools for process improvement and defect reduction, such as DMAIC (Define, Measure, Analyze, Improve, Control) and statistical analysis techniques.

The Quality Assurance Engineer is responsible for delivering results as a vital member of the Quality and cross-functional teams representing the customers' best interests, assuring hardware & software and process quality and effectiveness throughout the product life cycle from design through post-delivery support. Skilled at developing and implementing quality plans, programs, and procedures using quality control methods, lean manufacturing concepts, and analyses. Ensures product quality conforms to established company, customer, and regulatory requirements. Reviews analyzes and reports on quality discrepancies related to assemblies and processes. Responsibility may include planning and implementing process quality plans for new hardware, software, or process introductions.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.· Bachelor's Degree in a technical discipline from an accredited University or College.· Minimum of 8 years of experience in quality. Experience in mid to large size matrix organization, preferably in high technology, for automotive, or semiconductor companies.· Extensive background in applicable quality and lean tools/techniques to include: APQP, FMEA, Control Plan, RCA, PPAP, Gage R&R, VSM, SPC, Poka-Yoke, Kaizen,8D, and QMS methods.· Ability to engage early in the planning stages to characterize sourcing, manufacturability, or programmatic risk to ensure product quality performance.· Hands-on engineer that has experience in hardware and software development, design reviews, manufacturing, manufacturing engineering, product integration.· Has created, reviewed, and implemented policies and procedures, work instructions, and test procedures, including Design Input, Design Output, Design Verification and Product Validation (V&V), and Change Management.· Possesses audit skills for product and process audits internally, at suppliers, and customer integration sites.· Knowledge of Quality Management Systems ISO9001, IATF 16949 preferred.· Fundamental understanding of problem-solving methods and statistical tools to define and analyze problems and evaluate and complete improvement projects.· Ability to work on and or lead projects with cross-functional teams. · Open-minded, Collaborative, Self-starter, Takes Ownership

You will be in responsible for developing and executing equipment and process validation projects with a quality focus and risk-based approach. You will interact on a daily basis and develop strong relationships with Operations, Quality, Process Engineering, Planning, and other key internal/external stakeholders ( R&D, Supply Chain, etc.). Experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. Develop, establish, and maintain quality engineering methodologies, systems, and practices which meet MilliporeSigma, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site and divisional quality goals and priorities. Responsible for design transfer validation of New Product Introduction (NPI) to manufacturing at MilliporeSigma Danvers, MA site. Primary Responsibilities: Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives. Driving cost reduction projects and reviewing/analyzing/improving the effectiveness of quality improvement tools and programsLeads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Application Validation Plans.Leads the execution of Risk Management deliverables to ensure compliance to ISO 9001 and demonstrates a primary commitment to patient safety.Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, customer complaint investigations, and CAPA's.Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls for product validation, process validation, and applicable validation activities.Manage project schedules with strict adherence to critical milestones to ensure quality and security of supply to EMD Millipore customers. Coach and mentor new and junior members of the team.Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Lead in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validationProactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance eventsLead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs and FTA.Lead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.Executing/supporting material qualification projects and leading/assisting with investigations related to raw materials/components.Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls (CTQ, CQA, CPP) for product validation, process validation, and applicable validation activities.Review the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes.Generate CTQ monitoring data for equipment and processes.Performing root cause analysis and corrective actions for process and equipment-related quality issuesProvides project direction, coaching, and mentoring for engineering and technical team personnel.Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.Supports internal and external regulatory audits.Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes.Support development, implementation, and training of site quality initiatives. Who you are:Basic Qualifications7+ years validation experience handling of multiple projects within the biopharma, biotech or medical device industries.Minimum B.S. degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Biochemistry or equivalentFull understanding of product, equipment and process validationDemonstrated capability of applying risk management concepts and toolsHands-on experience in troubleshooting and the application of quality system standardsExperienced at working in cross-functional teamsStrong written and verbal communication skills (internal/external)Strong teamwork and collaboration skillsExperience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processesExperienced with Quality & GxP IT compliance requirements Preferred Qualifications:ASQ Quality Engineer Certification (CQE)Six Sigma CertificationQuality by DesignApplied/industrial statistics experienceDetailed Knowledge of GMP, ISO and FDA design and development quality requirementsKnowledge of aseptic processing

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