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Sr. Design Quality Engineer

Seattle, WA 98108

Posted: 04/30/2018 Employment Type: Direct Hire Industry: Biotech/R&D/Science Job Number: 18372

Position Title:  Sr. Design Quality Engineer

Position Description:  Protingent Staffing has an exciting direct hire opportunity with our client in Seattle, Washington.

Job Requirements:
  • Provide quality engineering and reliability input to all new projects, including the establishment of quality and reliability design constraints and design evaluation criteria.
  • Plan, coordinate, execute and lead design verification testing against product requirement specifications
  • Oversee the Risk Management program, including creating Risk Management Plans, coordinating risk analyses, participating in FMEA’ s, and maintaining Risk Management Reports and Files.
  • Participate in design reviews to ensure customer and regulatory requirements have been properly translated in to design inputs which are complete, unambiguous and do not conflict.
  • Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.
  • Develop an understanding of the current product to assist with product updates and maintenance releases.
  • Assist in the preparation of design documentation to ensure the Design History File is maintained.
  • Assist with creating Essential Requirements Checklists and Technical Files for EU submissions.
  • Create, implement and teach new quality systems as required.

Job Qualifications:
  • BS degree in Engineering discipline or equivalent degree + experience
  • Minimum of  eight years’ experience in engineering related industry, of which  5 years should be in the medical device industry.
  • Direct experience with FDA QSR and ISO 13485 compliance.
  • Knowledge of development, validation and manufacture of medical devices.
  • Direct experience with electro-mechanical equipment required, including IEC

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

Gazelle Medina
Sr. Technical Recruiter

I have been a Technical recruiter for over 20 years, much of that time with Protingent.  My passion is teaching people how to manage their career and effectively look for work.  I will keep working with a candidate until we find that right fit. I want to know what your dream job would be so I can help you find it.

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