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Quality Engineer

4 months ago

Irvine, United States Cypress HCM Full time

Quality Engineer II


How You'll Make An Impact:

  • Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including:
  • Analysis of post market data and reviewing completed reports with business partners.
  • Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
  • Maintain, archive and completed controlled quality records.
  • Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
  • Facilitate and/or chair local/regional PMS Board meetings.
  • Support various QMS and PMS projects (local and global) as needed.
  • Support internal/external audits as needed.
  • Perform other related duties and assignments as needed.

What You Bring:

  • Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
  • Experience in a regulated manufacturing industry or equivalent combination of education and experience.
  • Understanding of GMP and quality system standards as they apply to products manufactured.
  • Understanding of product post market surveillance requirements for IVD products a plus.
  • Working knowledge of device/drug/biotech manufacturing processes.
  • Detail-oriented and ability to multitask.
  • Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
  • Advanced technical writing and word processing skills.
  • Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus


Up to $52/hour DOE