More jobs:
Quality Engineer
Job in
Foothill Ranch, Orange County, California, 92610, USA
Listed on 2026-09-06
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-09-06
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Regulatory Compliance Specialist
Job Description & How to Apply Below
Quality Engineer
We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.
The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.
Roles & Responsibilities:
- Support Medical Device Quality Engineering activities.
- Collaborate with R&D, Regulatory, and cross-functional engineering teams.
- Support Design Controls and Risk Management activities.
- Participate in Verification & Validation (V&V) activities.
- Support Change Control and CAPA processes.
- Ensure compliance with GxP requirements.
- Provide Product Development support.
Education & Experience:
- Bachelor's degree in Engineering or a related field.
- 2+ years of Medical Device Quality Engineering experience.
- Strong knowledge of Design Controls, Risk Management, and Regulatory Compliance.
- Excellent communication and problem-solving skills.
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