Quality Engineer II - Medical Devices, Catheters Job at Cambridge Recruiters, San Jose, CA

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  • Cambridge Recruiters
  • San Jose, CA

Job Description

Quality Engineer II / III (Title Flexible)

Full-Time Permanent position, and reports to a Director of QA/RA

Responsibilities

  • Participant on cross-functional project teams, contribute to product specification development, author/approve documents for design verification and validation, lot release testing, etc.
  • NCR's, Document non-conformances, including root cause and corrections
  • Corrective Actions - CAPA's, performing thorough root cause investigation and documenting corrective and preventative action plans
  • Assist with risk analysis activities and maintaining up to date risk management documents
  • Determine quality improvements for manufacturing processes
  • Write and execute Validation Protocols (IQ/OQ/PQ's)

Qualifications

  • BS or MS Engineering degree
  • 2-4+ years' of Medical Device Quality Engineering experience
  • Strong knowledge of quality tools used in the industry
  • Analytical and quantitative approach to problem solving
  • Excellent Communication skills
  • Must Have US Work Authorization or be a US Citizen (No H1B Visa transfers)

Company Info:

Well-funded, 40-Person Medical Device Incubator that recently achieved 510K approval on flagship Interventional Vascular Device. The leadership team has previously launched and exited multiple medical device product companies in the past.

Local Candidates strongly preferred

Strong preference given to candidates with Catheter/Vascular Device experience

Job Tags

Permanent employment, Full time, Local area, H1b, Flexible hours,

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