More jobs:
Sr Quality Engineer II - Combination Products
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry, Regulatory Compliance Specialist
Job Description & How to Apply Below
Role:
Lead Quality Engineer for medical device combination products, focusing on design controls, risk management, and lifecycle quality oversight.
Responsibilities:
- partner with Device Engineering on development activities
- ensure compliance with FDA, ISO, and Gilead quality standards
- lead quality improvement initiatives
- resolve complex technical and quality issues with cross-functional teams and CMOs
- support change control assessments
- and develop controlled documentation.
- Bachelor's in Engineering or scientific discipline with ≥8 years (Master's with ≥6 years) of relevant QA experience, with strong background in medical devices and combination products.
- 10+ years supporting combination products like autoinjectors or pre-filled syringes, expertise in design controls, risk management (ISO 14971), statistical methods, process improvement, and manufacturing operations.
- medical device/combination product focus
- lifecycle management
- design verification/validation
- risk management
- regulatory compliance
- and cross-functional collaboration.
- Not specified.
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