Regulatory Quality Engineer
On-siteKenosha, Wisconsin, United States
Job Summary
Conduct quality system management for Elmhurst and Kenosha facilities by establishing, implementing, and maintaining processes aligned with FDA 21 CFR 820, GMP, and ISO 13485 standards. Lead vendor, internal, and external audits while coordinating root cause determinations, CAPA, and MRB activities to ensure regulatory compliance. Manage FDA registrations, device listings, and master validation programs, including site and product validations. Develop process flows, training programs, and metrics to drive value-add improvements across the organization. Resolve quality issues with suppliers and coordinate manufacturing process validation with internal and external stakeholders.
Required Qualifications
- Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M
- Familiarity with test methods and standards for the design, verification, and validation of medical device products
Desired Qualifications
- Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering
- five to ten years of experience in medical device manufacturing industry and in the quality engineering role
- training
- Knowledge of the medical device manufacturing industry
- Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.