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Senior Design Control Quality Engineer

Company: TSP
Location: Racine
Posted on: May 10, 2022

Job Description:

Key Responsibilities
- Quality lead on design change projects - support sustaining engineering, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products
- Originate, review, and approve internal documents, operating procedures and specifications through the Design Change process
- Facilitate Risk Management activities such as annual product risk file review, pFMEA, review of IFU, CER, PMS documents etc.
- Act as SME supporting other quality system activities (CAPA, NCR, Post Market Surveillance, New Market introduction, Audits etc.)
- Facilitate continued compliance and certification to international regulations for Medical Devices

- BS in a Physical Science or Engineering, or equivalent experience required.
- ASQ Certification as a Quality Engineer or equivalent preferred
- BS Engineering preferred

6 years' experience in Medical Device, at least 4 years in Quality
Experience with energy-based devices required
Software experience preferred

Must be able to pass vision testing requirements (with or without corrective eyewear).
- 20/20 Near Acuity Vision

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Keywords: TSP, Racine , Senior Design Control Quality Engineer, Engineering , Racine, Wisconsin

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