Director Device Quality

AstraZeneca • Gaithersburg, MD

8d

About The Position

This role provides senior-level leadership for quality oversight of commercial combination products and devices. The Director will oversee design transfer, process validation, and build a team environment that embodies AZ's core values and facilitates growth. This position involves partnering with key stakeholders to align on strategic imperatives and approaches, leading medical device and combination product quality system initiatives, and developing strategies for no-market support. The role requires working knowledge of global regulations to ensure compliant manufacture of product and providing expert guidance for post-market data and design controls.

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director