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Senior Quality Engineer
ATR InternationalNorth Haven, CT, United States10 days ago
Job type
- Full-time
Job descriptionBachelor’s degree in Engineering (or related field) 4+ years’ experience in Quality or Engineering (regulated industry preferred) Strong skills in risk management, design verification, and NPD quality tools Proficiency with Minitab / statistical analysis and knowledge of ISO 13485 ASQ Certified Quality Engineer (CQE) Experience with medical device standards (ISO 13485, ISO 14971, IEC 60601) Understanding of software / hardware interfaces Risk Management (Hazard Analysis, DFMEA, UFMEA) Design Verification Authoring & Execution General NPD Quality Engineering (Change Control, CAPA, ISO 13485)
Our client is seeking a Senior Quality Engineer to support new product development in the Surgical Instruments division. The role is a key member of the Quality team, working closely with cross-functional partners to ensure product quality, regulatory compliance, and continuous improvement.
Key Responsibilities
- Partner with R&D to define and execute design verification & validation testing
- Lead and support risk management activities (Hazard Analysis, DFMEA, UFMEA, complaint analysis)
- Contribute to design and process validation planning and execution
- Collect and analyze data, prepare reports, and provide recommendations
- Solve complex quality and process challenges independently
Qualifications
Preferred
Top 3 Skills Required
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Senior Quality Engineer • North Haven, CT, United States
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