Quality Engineer II

Pay Rate Low: 40.00 | Pay Rate High: 44.00

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.

Location:

Irvine, CA (Onsite)

Contract:

12 month Contract with extension or conversion potential
Benefits:
Medical, Dental, Holiday, PTO, 401K matching
Pay:  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.

• 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

• 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!

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.