Senior Quality Device Engineer- Operations

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 world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca's priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events

What you'll do:

The Sr. Quality Device Engineer will provide technical quality leadership and support for West Chester combination products. This role will partner 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. The role will be responsible for leading quality planning and risk management activities, as well as to provide sustaining engineering support through post-market surveillance and design changes.
  • Lead medical device and combination product Quality System initiatives at West Chester. Develop strategies, priorities, and plans as required.
  • Support activities related to the Combination Product and Medical Device Quality Management System, ensuring compliance to all applicable regulations.
  • Authoring, compilation and maintenance of 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)
  • Support actions required as a result of updates to standards or new applicable standards.
  • Lead projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.
  • Provide quality engineering support for the handling and trending of device design related complaint records.
  • Author or provide quality guidance in the handling of nonconformance and CAPAs related to the medical device quality systems.
  • Provide quality and technical support for the evaluation of change assessments for combination products and quality system.
  • Work with suppliers to address development, risk management, change control, quality or auditing activities.
  • 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.

Essential for the role:
  • BS and/or MS 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.

Desirable for the role:
  • Experience with Health Authority interactions
  • ASQ certification (CQE, CBA, CQA or CRE)
  • Six Sigma Certification

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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About Operations

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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