Job Description

Exciting 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 I
Location: Irvine, CA
Industry: Medical Devices
Pay: 32.60-43.50 DOE
Contract: 12 month contract with potential extension to 18 Months or conversion
Benefits: Medical, Dental, Holiday, PTO 401K matching
Hours: Mid Shift (Mon-Fri, 12 PM-9 PM) (Training on 1st shift)

We're seeking a Quality Engineer I to ensure product excellence and regulatory compliance across manufacturing and post-market performance. You'll lead investigations, drive continuous improvement, and represent Quality in cross-functional teams-all while supporting the lifecycle of life-changing medical devices.

Key Responsibilities:

• Investigate and resolve product and process quality issues (customer complaints & nonconformities).
• Lead root cause analysis, CAPA implementation, and effectiveness monitoring.
• Analyze product performance using data-driven, risk-based methods.
• Collaborate across teams to support quality initiatives and regulatory compliance.
• Ensure adherence to FDA, ISO 13485, and company quality systems.
• Troubleshoot returned devices and document technical findings.

What You Bring:

• Bachelor's in Engineering.
• 2+ years in a regulated industry (medical device/FDA preferred).
• Solid understanding of FDA (21 CFR 820/803) and ISO 13485 standards.
• Strong skills in problem-solving, risk analysis, and technical communication.
  This 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!
  INDBH
  #LI-DNP:

Job Tags

Full time, Contract work, Shift work, Day shift,

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