Director Device Quality

AstraZeneca; Gaithersburg (MD); On-site; USD 175,000 - 262,000; Full time

Benefits offered by this job

Retirement plans

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca in Gaithersburg, MD seeks a Senior Quality Leader to oversee the quality systems for commercial combination products and devices. You will drive design transfer, process validation, and regulatory compliance while building a high-performing team.

You will partner with stakeholders to set strategic imperatives, advance post-market data guidance, and ensure global standards (21 CFR, ISO 13485) are consistently applied. This role demands extensive experience and proven leadership.

Qualifications

• BS or MS in engineering or equivalent field.
• 15+ years of experience in quality engineering for combination products and devices.
• Extensive knowledge of global QMS requirements (21 CFR Parts 4, 210, 211, 803, 806, 820; ISO 13485).
• Extensive knowledge of US and international Design Control and Risk Management (21 CFR 820.30, ISO 13485, ISO 14971, MDD 93/42/EEC).
• Proven leadership in building and growing a team.

Responsibilities

• Senior level leadership of quality oversight for commercial combination products and devices.
• Oversee design transfer, process validation.
• Build a team environment embodying AZ core values and fostering 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 compliance with global regulations in manufacturing.
• Provide guidance for post-market data and improvements.
• Senior guidance on design controls for post-market activities.

Skills

Quality leadership

Quality engineering

Design controls

Regulatory compliance

Stakeholder collaboration

Team building

Education

Engineering degree

Job description

Individual responsibilities will include:

• Senior level leadership of quality oversight of commercial combination products and devices
• Oversee design transfer, process validation and
• 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
• 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 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

Desirable Requirements:

• 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.

The annual base pay (or hourly rate of compensation) for this position ranges from $174,856.80 to $ 262,285.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

10-Sep-2026

Closing Date

20-Sep-2026

Our 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.