Quality Engineer - Medical Devices & Validation Compliance
Job in
Livonia, Wayne County, Michigan, 48153, USA
Listed on 2026-09-04
Listing for:
TriMas Packaging Group
Full Time
position Listed on 2026-09-04
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Omega Plastics Inc. is seeking a Quality Engineer to drive compliance and QA engineering for medical devices and components, including development of validation programs, quality plans, pFMEAs, and process control plans to ensure safety and regulatory alignment.
Responsibilities include IQ/OQ/PQ protocol development, risk assessment, supplier and client coordination, and maintaining 21 CFR 820 and ISO 13485 compliance through audits and documentation.
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