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


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


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