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Applications engineer • worcester ma
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Senior Quality Engineer
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UMass Med SchoolWorcester, MA, United StatesENVIROMENTAL ENGINEER
GpacWorcester, Massachusetts, United StatesSenior Quality Engineer
Michael PageNorthborough, MA, US- serp_jobs.job_card.full_time
Senior Quality Engineer
A dynamic, medium-sized medical device company with a collaborative, family-like culture, focused on catheter-based solutions. The team partners globally across sites, fostering growth opportunities, technical development, and career mobility within a supportive environment.
Job Description
Senior Quality Engineer :
- Ensure Design Compliance : Oversee product designs to ensure compliance with regulatory standards (e.g., ISO 13485, FDA requirements) and company quality policies.
- Risk Management : Conduct risk assessments, including Failure Modes and Effects Analysis (FMEA), to identify and mitigate potential design and process risks.
- Design Validation and Verification : Lead validation and verification activities to confirm that products meet design specifications and intended use requirements.
- Quality Standards Implementation : Collaborate with design and engineering teams to integrate quality standards into the product development process.
- Process Improvement : Drive continuous improvement initiatives in design and manufacturing processes to enhance product quality and efficiency.
- Customer and Regulatory Support : Serve as a quality representative during customer audits and regulatory inspections, ensuring readiness and compliance.
- Documentation Management : Develop and maintain quality documentation, including design history files (DHFs) and technical reports.
- Problem Solving : Investigate and resolve design-related quality issues using root cause analysis and corrective action methodologies.
- Cross-Functional Collaboration : Partner with engineering, manufacturing, and project management teams to support product launches and resolve quality challenges.
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 Applicant
Senior Quality Engineer :
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