Associate Director, Device Quality
About The Position
Introduction to role: Are you ready to set the standard for device quality that protects patients and enables faster access to medicines? This role leads quality oversight for commercial medical devices and combination products, shaping how we design, transfer, validate, manufacture, and continuously improve products that people depend on every day. You will guide high-stakes decisions across the product lifecycle, from design controls and process validation to post-market data insights. Working with scientists, engineers, manufacturing and supply teams, you will turn thorough quality principles into practical solutions at scale. Do you thrive in sophisticated environments where disciplined execution meets bold thinking and measurable impact? Accountabilities: Senior level leadership of quality oversight of combination products and devices Oversee design and development, design transfer, process validation and on-market support Establish a team environment that embodies AZs core values 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 on-market support Working knowledge of global regulations to ensure compliant manufacture of product 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
Requirements
- Seven (7) years or more of experience supporting Quality Engineering of Combination Products and Devices
- BS and/or MS in engineering or equivalent discipline
- 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
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 combination products and devices
- Oversee design and development, design transfer, process validation and on-market support
- Establish a team environment that embodies AZs core values 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 on-market support
- Working knowledge of global regulations to ensure compliant manufacture of product
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
