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Sr. Supplier Quality Engineer

Seattle, WA 98108 | Direct Hire

Post Date: 04/30/2018 Job ID: 18373 Industry: Biotech/R&D/Science

Position Title:  Sr. Supplier Quality Engineer

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

Job Requirements:
  • Develop and execute audit plans for all relevant suppliers in compliance with Natus Medicals Supplier Qualification program.
  • Carry out onsite Supplier audits, report and follow up on audit results including any non-conformances.
  • Provide quality engineering support to new product development teams and Supply Chain Management.
  • Identify, initiate and follow through of Supplier Corrective Action Reports (SCAR) to ensure effective corrective/preventive actions are implemented.
  • Lead review meetings and provide and analyze key metrics.  Submit trends for possible Corrective and Preventive Actions.
  • Assist with the calibration and verification of tools and equipment when needed.
  • Write, review and/or approve product drawings/specifications, test protocol/reports, and inspection processes.
  • Devise and execute experimental studies, including GD&T, Gage R&R, tolerance stack ups, etc.
  • Work with supplier to help improve process capabilities, including providing input into process validation activities, such as 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.  Work with the supplier to correct non-conformances.
  • Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
  • Provides guidance and oversight to maintain the RoHS progam.
  • 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 recommended.
  • Quality Systems Lead Auditor certification required.
  • Must be willing and available to travel frequently to various supplier sites.

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.

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