Medical Device Design Quality Engineer

Philadelphia, PA

Job ID: 121123 Industry: Quality

Medical Device Design Quality Engineer


Our client is a large medical device manufacturer. They manufacturing a number of class 2 and 3 medical devices. They are in need of a Design Quality Engineer to come in and help with Tech File remediation

Duties/Responsibilities/Scope of Work:

·          Remediation of existing Risk Management documentation (Design & Clinical Risk Management, Risk Management Report, and Risk Management Plan) to the Product Risk Management Process.

·          Act as a sub-team leader for other Design Quality Engineers supporting Risk Management, DHF and DFMEA remediation.

Required Skills:

·          A minimum BS degree in a technical discipline with five plus years related experience as a Quality Engineer in the medical device industry.

·          Strong background in Risk Management with experience in creation, review, and approval of risk management documentation (DFMEAs and PFMEAs) for Design History Files.

·          Strong analytical skills

·          Proficient in Microsoft Office (Excel, Word, etc.)

Job Type: Contract 

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