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Senior Quality Engineer

Seattle, WA 98108

Posted: 01/04/2018 Employment Type: Direct Hire Industry: Biotech/R&D/Science Job Number: 17904

Position Title:  Senior Quality Engineer

Position Description:  Protingent Staffing has an exciting opportunity with our client in Seattle, WA. The Senior  Quality Engineer is responsible for overseeing the quality of products from Design Transfer, Production and Post-Production activities.

Job Requirements:
  • Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.
  • Work with New Product Development to effectively transfer new product designs into the manufacturing process.  Assists with the creation of Design Transfer documentation.
  • Assist in developing manufacturing processes and optimizing current processes to improve reliability. 
  • Establish process monitoring goals using appropriate statistical techniques.
  •   Devise and execute experimental studies, including GD&T, Gage R&R, DOE, etc.
  •   Provide input into process validation activities, including IQ, OQ and PQ requirements.
  • Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
  •   Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.
  •   Participate in the Risk Management program, including updating risk analyses, participating in Process FMEA’ s, and maintaining Risk Management documents.
  •   Perform analysis of returned goods, document findings and conduct trend analysis of the results. 
  • Submit trends for possible Corrective and Preventive Actions.
  •   Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
  •   Use relational databases and reporting tools to collate and analyze quality data.  Have knowledge of and use statistical data analysis tools (e.g. Minitab).
  •   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.
  •   Experience with electro-mechanical equipment required. 
  • Experience with 60601, UL and EMC requirements a plus. 

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.

 

James Sturgeon

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