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QA Specialist IV, Supplier Quality (Device) - Operations

Location Gaithersburg, Maryland, United States Job ID R-057718 Date posted 08/05/2019

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.

***This position is posted as a QA Specialist / Senior Specialist based on experience.***

As the QA Specialist IV, you will provide technical quality leadership and support for Gaithersburg combination products within the External Quality Department. You will partner with internal (CMC teams, DFDD and Device Quality) and external partners (CMOs and partners) for qualification and monitoring of CMOs, suppliers and partnerships utilized in AZ clinical development. This role needs product development expertise and experience with product design history and risk management processes as well as with FDA 21 CFR requirements and international standards.

In this position, you will be responsible for assisting in the development of a quality oversight model and risk assessment process with CP and devices. This role will be also responsible for monitoring of qualified suppliers and the assessment and triage of Supplier Initiated Changes (SICS) or engaging the appropriate SME for assessment.

Essential Job Functions:

  • Lead medical device and combination product External Quality initiatives for Development Quality. Develop strategies, priorities, and plans as required.
  • Liaison with Device Quality or represent External Quality with other groups relating to Combination Product and Medical Device Quality Management, ensuring compliance to all applicable regulations and internal processes.
  • Authoring, compilation, negotiation and maintenance of Quality Agreements that ensure compliance and operational operability with Gaithersburg and AZ’s greater processes.
  • Interact and have primary knowledge of 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) as necessary to oversee External Suppliers
  • Support processes to establish new or modify existing processes to qualify and monitor external suppliers (e,g. risk assessments, audits)
  • Manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.
  • Provide External Quality support for device related product complaint records.
  • Manage the handling of nonconformance and CAPAs related to the medical device quality systems, interacting with internal and external groups as necessary.
  • Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system.
  • Interface with suppliers to address development, risk management, change control, quality or auditing activities.
  • Work cross-functionally to represent the External Quality Group in the selection of device suppliers.
  • Interact with DFDD as necessary to ensure all suppliers utilized for GMP activities are recognized and qualified at an appropriate time.
  • Influence Device Quality and CMC groups in the selection and use of appropriate device suppliers.
  • Maintain up-to-date training on relevant safety requirements, SOPs and other controlled documents

Minimum Requirements:

  • BS and/or MS in engineering or equivalent technical discipline
  • 3+ years of experience supporting Quality Engineering of Combination Products and/or Medical Devices for the Senior Specialist role.

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.



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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