# Head of Quality, Device and Combination Products

Hiring organization: [Biogen](https://career.thegoodapps.co/organizations/biogen)

Canonical page: https://career.thegoodapps.co/jobs/c4e832a5-e510-4abb-ac8c-92da3f79b1e4

Listed on Biogen's own careers site. Applications go to them directly.

- Seniority: Senior
- Location: Cambridge, MA

## Summary

Lead the quality strategy and global team for medical devices and combination products at a major biotech company, from design through lifecycle management. This role suits an experienced quality professional with deep regulatory knowledge and demonstrated leadership in device manufacturing compliance.

_Our summary, not Biogen's wording._

## Skills named

ISO 13485

## Required

- BS in Chemical Engineering, Mechanical Engineering, or relevant field
- Minimum 12 years medical device quality and engineering experience
- At least 5 years in clinical quality operations or device quality
- Knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU Medical Device Regulation
- Regulatory authority and notified body engagement experience
- 5+ years people management experience
- Project management experience
- CMO supply chain activities understanding
- International matrix environment experience
- Supplier management and negotiation skills
- Process development and validation experience

Apply on Biogen's site: https://biibhr.wd3.myworkdayjobs.com/en-US/external/job/Cambridge-MA/Head-of-Quality--Device-and-Combination-Products_REQ23514-1