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Sr. Post-Market Quality Engineer

  • Job type: Permanent
  • Location: Greensboro, North Carolina
  • Salary: Negotiable
  • Job reference: 291611/010_1559936089
  • Sector: Quality Control, EPM Scientific
  • Date posted: 07/06/2019

Post-Market Quality Engineer

Greensboro, NC

A global medical device company in Greensboro, NC is looking to bring on a Post-Market Quality Engineer!

Primary Responsibilities:

  • Support all post-market quality engineering activities

  • Execute and maintain post-market procedures and processes

  • Review and update risk management files for all products including reportable product harms and malfunctions

  • Participate in design control activities

  • Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, and vendor inspections

Ideal Candidate:

  • 5+ years or equivalent experience in quality engineering role

  • CQE

  • Six Sigma

  • Project Management training desirable

  • BS degree in engineering, MS degree is desirable

  • Experience with full product development lifecycle through commercialization

  • Experience in product and process risk management

  • Experience in post-market surveillance activities

  • Expertise in QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211

  • Ability to travel 10% of the time

Apply now!

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