Quality Engineer II - Medical Devices, Post-Market Job at Cambridge Recruiters, Santa Clara, CA

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  • Cambridge Recruiters
  • Santa Clara, CA

Job Description

Established publicly-held medical device catheter manufacturer is looking for a Quality Engineer II to add to their Post-Market Quality Engineering/Complaints Analysis team.

Responsibilities

  • Perform Returned Goods and failure analysis on returned products
  • Perform Complaints Investigations & Ensure complaints are prioritized based on patient, product, and compliance risk.
  • Perform Failure problem identification, resolution, loss reporting and continuous improvement
  • Design and implement methods for process control, process improvement, testing and inspection
  • Lead continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
  • Develop, execute, and analyze quality reporting measures
  • Lead/Participate the Product Experience Review (PER) and Quality System Management Review for the Post Market Surveillance Process
  • Compile quality metrics, QA logs and databases, reports for posts-market activities.

Qualifications

  • BS or MS degree in Mechanical, Biomedical, or Manufacturing Engineering
  • 2-3+ years' of medical device manufacturing/quality engineering experience
  • Strong knowledge of quality tools used in the industry
  • Analytical and quantitative approach to problem solving
  • Excellent written and verbal communication skills
  • Knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems

Full-Time Permanent Position

Full Benefits (Medical, 401K Match, tuition reimbursement)

This is an on-site position (NOT Hybrid).

Local Candidates preferred, however well-qualified candidates from outside the area may also be considered.

US Citizen or candidates with Work Authorization that don't need sponsorship preferred

Job Tags

Permanent employment, Full time, Local area,

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