Director Device Quality
About The Position
This role is for a Director of Device Quality, responsible for senior-level leadership of quality oversight for commercial combination products and devices. The position involves overseeing design transfer, process validation, and building a team environment that embodies core values and facilitates growth. The Director will partner with key stakeholders to align on strategic imperatives and approaches, lead medical device and combination product quality system initiatives, and develop strategies for no-market support. A working knowledge of global regulations is essential to ensure compliant manufacture of product, and the role requires ensuring strategic improvements related to combination product and medical device quality management systems are in compliance with global regulations. The Director will also provide expert guidance for post-market data and senior-level guidance on design controls for post-market activities.
Requirements
- BS and/or MS in engineering or an equivalent field or equivalent experience
- Fifteen (15) years or more of experience supporting Quality Engineering of Combination Products and Devices
- Extensive knowledge of global Quality System requirements (specifically 21 CFR Parts 4, 210, 211, 803, 806, & 820, and ISO 13485) required
- Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC), as well as other applicable standards required
- Leader with proven history of building and growing a team
- Working knowledge of global regulations to ensure compliant manufacture of product
Nice To Haves
- Experience with Health Authority interactions
- Ability to lead efforts at the site and influences the regional and global Quality organization to create policy, provide guidance and influence senior Leaders in the area of GMP Device and Combination Product compliance.
Responsibilities
- Senior level leadership of quality oversight of commercial combination products and devices
- Oversee design transfer, process validation
- Build a team environment that embody’s AZs corevalues and facilitates growth
- Partner with key stakeholders to align on strategic imperatives and approaches
- Lead medical device and combination product quality system initiatives
- Develop strategies for no-market support
- Ensure that strategic improvements related to combination product and medical device quality management system in compliance with global regulations
- Provide expert guidance for post-market data
- Sr. level guidance on design controls for post market activities
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
- opportunity to receive short-term incentive bonuses
- equity-based awards for salaried roles
- commissions for sales roles
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What This Job Offers
Job Type
Full-time
Career Level
Director
