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Quality Engineer II

Job

Astrix Technology

Irvine, CA (In Person)

Full-Time

Posted 6 days ago (Updated 4 days ago) • Actively hiring

Expires 7/19/2026

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Job Description

  • Quality Engineer II
  • Engineering Irvine, California, US + Added - 16/06/2026 Exciting Quality Engineer II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision Care
  • Quality Engineer II
  • Location:
  • Irvine, CA (Onsite)
  • Contract:
  • 12 month Contract with extension or conversion potential
  • Benefits
  • : Medical, Dental, Holiday, PTO 401K matching
  • Pay:
  • 40.00-44.00 doe We are seeking a Quality Engineer II to support manufacturing quality and post-market performance activities for medical devices. This role will lead investigations, drive corrective actions, analyze product performance data, and ensure compliance with quality and regulatory requirements.
  • Key Responsibilities:
  • Lead root cause investigations for manufacturing and customer quality issues
  • Develop and implement corrective and preventive actions (CAPA)
  • Analyze product performance using risk-based and statistical methods
  • Troubleshoot returned devices and manufacturing nonconformances
  • Collaborate with cross-functional teams on quality improvement initiatives
  • Ensure compliance with
FDA, ISO
13485, and Quality System requirements
  • Qualifications:
  • Bachelor's degree in Engineering required
  • 3+ years of quality engineering experience in a regulated industry
  • Medical device or manufacturing experience preferred
  • Knowledge of
FDA 21 CFR
Part 820, Part 803, and
ISO 13485
standards This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Work Authorization Requirement Candidates must be authorized to work in the United States on a permanent basis. Sponsorship (including H-1B, OPT, CPT, etc.) is not available for this role now or in the future. INDBH \#LI-RL1We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.