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 peoples exceptional skills with those of people from all over the globe. As a Sr. Device Quality Engineer in Gaithersburg, MD, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
The Sr. Device Quality Engineer will provide technical quality leadership and support for Gaithersburg 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 compliant with FDA 21 CFR requirements and international standards.
The Sr. Device Engineer will be responsible for leading quality planning and supporting risk management activities, as well as to provide sustaining engineering support through post-market surveillance, design changes, etc.
The Sr. Device Quality Engineer will be part of the efforts at the site to transform Gaithersburg into a Center of Excellence in Combination Products and Medical Devices.
Essential Job Functions:
- Lead medical device and combination product Quality System initiatives at Gaithersburg. 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.
- Manage 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 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 the device quality system.
- Interface with suppliers to address development, risk management, change control, quality or auditing activities.
- Work cross-functionally to implement product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities.
- Develop risk-based sampling plans for design verification and validation testing.
- Lead risk management (e.g. FMEA) and quality planning activities.
- Lead design control gap assessments, remediation planning, and remediation execution as required.
- Support New Product Introduction (e.g. Prefilled Syringes, Auto injectors, etc).
- Influence regional and global Quality policies/processes and influence senior leaders in the area of GMP Device and Combination Product compliance.
- Maintain up-to-date training on relevant safety requirements, SOPs and other controlled documents
- BS and/or MS in engineering or equivalent technical discipline
- 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 (ISO 11608 series, ISO 62304, etc.).
- Development experience with combination products including injection (pre-filled syringes, autoinjectors, on body injection) and/or inhalation devices.
- Experience with Health Authority interactions
- ASQ certification (CQE, CBA, CQA or CRE)
- Six Sigma Certification
Next Steps Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.