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Design Quality Engineer
3 months ago
Role: Design Quality Engineer
Location: North Haven, CT
- Evaluate 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
- Update DFMEA and DHF documents as needed as part of the post market design change management process
- Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management
- 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
- 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
- Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings
- 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
- Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
- Excellent communication and technical writing skills
- Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments
- Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)