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Senior or Staff Quality Engineer

3 months ago

Santa Clara, United States Cambridge Executive Recruiters Inc Full time

Senior to Staff Quality Engineer Company: Class III Vascular & Implantable device startup, 25 people They're very close to FDA PMA approval, so will be ramping up soon Location: Santa Clara, CA Primary Responsibilities: Manufacturing Quality: NC's, CAPA, Complaints & Product Failure Investigations; Author test reports for DV and Process Validations Design Quality: Risk Management, FMEA's; Design V&V, sterilization, biocompatibility, design transfer Supplier Maintenance - equipment validations, Investigation of non-conforming materials/components Job Requirements: BS Engineering Degree or other Scientific Discipline 4-7+ years Quality Engineering experience MUST HAVE Medical Device experience Ideal candidate will have experience with Catheter-Based interventional vascular devices or implantables. Need someone with strong technical skills, and a fast learner Need someone to hit the ground running Position will report to a Director of Quality Engineering. Full-Time Permanent position, full benefits, stock options, etc. Must Have Current US Work Authorization -

NO H1B Candidates , or Green Card Sponsorships Local Candidates Only - No Relocation Assistance Available About Us: 20 yrs recruiting experience for medical device companies. Candidate Testimonials:

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