Senior Specialist Device Quality

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue elite medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. 

As a Sr. Specialist Device Quality, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. We offer one of the most exciting, fast paced, and meaningful work environments in the world of operations, supply chain and manufacturing. 

In this role we will provide technical quality leadership and support for AstraZeneca combination products. This role partners with internal and external partners for product development and sustaining efforts to ensure product design history and risk management files are aligned with FDA 21 CFR requirements and international standards. 

We will lead quality planning and supporting risk management activities, as well as to provide sustaining engineering support through post-market surveillance, design changes, etc. 

Join us and be part of the efforts at the site to transform into a Center of Excellence in Combination Products and Medical Devices! 

Main Responsibilities: 

• Lead medical device and combination product Quality System initiatives at Gaithersburg. Develop strategies, priorities, and plans as required. 
• Influence regional and global Quality policies/processes and influence senior leaders in the area of GMP Device and Combination Product compliance. 
• Lead projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs. 
• Authoring, maintaining and compiling Design History File content, Conformity Assessments, and Device Master Record (DMR) 
• Author and review technical specifications and design control documentation (Design and Development Plans, FMEAs, User Requirements Specifications, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, and Design Transfer) 
• Provide quality engineering support for the handling device design related complaint records. 
• Author and provide quality guidance in the handling of non-conformance and CAPAs related to the medical device quality systems. 
• Provide quality and technical direction for the evaluation of change assessments. 
• Work multi-functionally to implement product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. 
• Lead risk management (e.g. FMEA) and quality planning activities; Develop risk-based sampling plans. 
• Lead design control gap assessments, remediation planning, and remediation execution as the need arises. 
• Support New Product Introduction (e.g. Prefilled Syringes, Auto injectors, etc). 

Minimum Requirements: 

• Bachelor Degree in engineering or equivalent technical field 
• Five (5) years or more of experience supporting Quality Engineering of Combination Products and/or Medical Devices 
• Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC), as well as other applicable standards required (IS