Associate Director, Device Quality

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 

Essential Skills/Experience:

• 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 

Desirable Skills/Experience:

• 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. 

Why AstraZeneca:

Here, quality leaders sit shoulder-to-shoulder with science, engineering, manufacturing and supply experts, turning complex pipelines into reliable products through cutting-edge technology, digital tools and sustainable practices. We rally around a clear purpose—bringing medicines that change lives to more people, faster—while valuing kindness alongside ambition. Expect a culture where unexpected teams share the same room, unleash bold thinking, and back it up with disciplined execution and investment. Your contribution will be visible, global and tied directly to patient outcomes.

Call to Action:

If you’re ready to shape device quality that safeguards patients and accelerates delivery, bring your leadership to AstraZeneca and make your mark today.

Date Posted

18-Feb-2026

Closing Date

18-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.