Quality Engineer II

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