Sr. Medical Device Quality Engineer

Hartford, CT

Industry: Medical Device Job Number: 147125


Sr. Medical Device Quality Engineer 

Our client is a large medical device manufacturer that develops a number of Class II & III Medical Devices. They are currently in need of a Quality Engineer to support sustaining engineering.  The Sr. Quality Engineer will be supporting engineering for a plant that will be moving operations to another country. They are looking for a " jack of all trades" Engineer that can work with cross functional teams.

• Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device development & testing, including CFRs, ISO, MDD, and other international/regulatory standards.
• Provide QE support for Engineering changes by reviewing Change Requests for compliance, completeness and accuracy
• Develop inspection criteria for components and finished devices
• Investigate incoming inspection issues
• Assist in the review and investigation of line failures
• Support the sustaining activities
• Provide product data analysis for CAPA investigation
• Investigate and resolve CAPA issues as needed
• Perform technical and non-technical product failure evaluations documenting and effectively communicating root cause findings.
• Skilled at performing reviews, system/product failure analysis, First Article Inspections (FAI), and Incoming Inspections, as required.
• Support new product development and product engineering by generating and/or processing key documents which may include quality plans, design review, risk and hazard analysis, verification and validation plans, product and process validation.
• Skilled in Internal Auditing and Lead Auditor duties.

  • SAP 

Job Type: Contract 

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