Medical Device Quality Manager

We are seeking an experienced Medical Device Combination Product Manager to provide Quality oversight for design control, design transfer, risk management, and sustaining activities associated with medical devices and combination products. This role will serve as a key Quality liaison across Product Development, Regulatory, Manufacturing, QC, and QA to ensure compliance throughout the product lifecycle.

Key Responsibilities:


- Bachelor's degree in Engineering, Science, or a related discipline, or equivalent regulated-industry experience.
- 7+ years of experience in combination product design control and/or medical device manufacturing, preferably spanning clinical through commercial phases.
- Strong knowledge of FDA 21 CFR Part 4/820, ISO 13485, ISO 14971, and EU MDR 2017/745.
- Experience with Design History Files (DHF), Design Controls, Risk Management, V&V, and Technology Transfer.
- Knowledge of ISO 11608 needle-based injection systems is a plus.
- Provide Quality oversight for medical device and combination product design control and design transfer activities.
- Support Design & Development Planning, Verification & Validation, Risk Management, Design Reviews, Technology Transfer, and Design History File (DHF) activities.
- Review and approve key quality and design control documentation, including
V&V protocols/reports, risk management files, transfer plans, and DHF deliverables.
- Ensure compliance with applicable device QMS regulations, standards, and procedures.
- Support CAPA, deviations, investigations, change controls, complaints, and risk assessments.
- Determine when Risk Management File updates are required throughout the product lifecycle and coordinate cross-functional execution.