More jobs:
System Designer
Job in
Warsaw, Kosciusko County, Indiana, 46580, USA
Listed on 2026-06-20
Listing for:
Mainz Brady Group
Full Time
position Listed on 2026-06-20
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Design Quality Engineer – SaMD (Design Controls & Compliance)
Drive quality and compliance for software-based medical devices—owning design controls, risk management, and documentation to ensure products meet rigorous regulatory standards.
Key Technical Skills- Software as a Medical Device (SaMD) & Design Controls
- DHF Management & Traceability (inputs/outputs, V&V, risk documentation)
- Risk Management & Regulatory Compliance (ISO 14971, FDA, IEC 62366)
Mainz Brady Group is an Equal Opportunity Employer. We are committed to Diversity & Inclusion and incorporate non-discrimination best practices in all our staffing processes. Mainz Brady Group does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, gender expression, age, disability or any other protected class.
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