Astrix Inc
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 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!
INDBH
#LI-DNP:
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 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!
INDBH
#LI-DNP: