About the role

NovintiX is seeking a Design Quality Engineer to drive DHF/QMS migrations, remediation, and design transfer across R&D, Regulatory, Manufacturing, and Quality teams. You will ensure DHF/DMR/DHR alignment with ISO 13485, FDA 21 CFR 820, and EU MDR, while leading risk management, V&V, and change control efforts. Ideal candidates hold a Biomedical/Mechanical engineering degree with 5–8 years in medical devices, and demonstrate excellent documentation and cross-functional collaboration skills.

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JOB OVERVIEW

Experience level

Manager

Location

Raynham, MA

Occupation

Validation Engineers

Industry

Electromedical and Electrotherapeutic Apparatus Manufacturing

Posted

8 days ago

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