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Quality Engineer II
Job
Astrix Inc
Irvine, CA (In Person)
$87,360 Salary, Full-Time
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Job Description
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 potentialBenefits :
Medical, Dental, Holiday, PTO 401K matchingPay:
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 requirementsQualifications:
- Bachelor's degree in Engineering required
- 3+ years of quality engineering experience in a regulated industry
- Medical device or manufacturing experience preferred
- Knowledge of