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Sr. Development Quality Engineer
Job in
Pleasanton, Alameda County, California, 94566, USA
Listed on 2026-01-12
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-01-12
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
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Job DescriptionYou’ll serve as a technical quality leader within a product development team, ensuring patient safety, product reliability, and full regulatory compliance across all phases of development.
Responsibilities- Lead Design Control and Risk Management activities from concept to commercialization.
- Support Verification & Validation (V&V) and Test Method Validation.
- Partner with cross-functional teams in R&D, Manufacturing, and Quality.
- Ensure compliance with FDA, EUMDR, and QMS standards.
- Bachelor's in engineering or related field (master's preferred).
- 5+ years in R&D, Manufacturing, or Quality Engineering (Medical Devices experience required).
- Strong expertise in Test Method Validation, Risk Documentation, and FMEA.
- Bonus:
Familiarity with DOORS, JIRA & statistical tools.
Mid-Senior level
Employment typeContract
Job functionQuality Assurance
IndustriesPharmaceutical Manufacturing
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