Sr. Supplier Quality Engineer
5900 First Ave S Seattle, WA 98108 | Direct Hire
Position Title: Sr. Supplier Quality Engineer
Position Description: Protingent Staffing has an exciting direct hire opportunity with our client in Seattle, Washington.
- 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.
- 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.