Senior or Staff Quality Engineer

2 weeks 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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