More jobs:
Manufacturing Quality Engineer
Job in
Mendota, Dakota County, Minnesota, 55150, USA
Listed on 2026-02-08
Listing for:
SciPro
Full Time
position Listed on 2026-02-08
Job specializations:
-
Engineering
Quality Engineering, Validation Engineer
Job Description & How to Apply Below
Responsibilities
- Support product release activities in compliance with FDA QSR and ISO 13485
- Author, execute, and review validation documentation (IQ/OQ/PQ, process and packaging validations)
- Prepare and maintain controlled engineering documentation, protocols, reports, and change records
- Support sterile barrier system validation activities, including seal strength, integrity, and package performance testing
- Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to ensure release readiness
- 3+ years of experience in aregulated medical device environment
- Hands-on experience with validation and controlled documentation
- Familiarity with thermoforming and package sealing processes is a strong plus
- Experience supporting packaging process validation and product release activities
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