Principal Device Quality Engineer
Netherlands – Breda
This key role in the Quality organization will assist with the design, development, commercialization and life-cycle sustaining support for Amgen’s mechanical, electro-mechanical, digital health and/or diagnostic devices as our device portfolio continues to expand rapidly in Europe. The role will be highly visible, interacting with cross-functional European and U.S. management team members to prepare for regional activities associated with Amgen’s medical devices, including regional requirements, inspection readiness and lifecycle management.
The position will report to a member of the Device Quality department leadership team and provide thought leadership and current best practices surrounding European considerations for the medical device lifecycle. The staff member will be located at the Breda location at Amgen, but report into the Corporate Quality function at the Thousand Oaks, California headquarters.
Specifically, this role will:
Employ quality principles and company’s procedures including but not limited to the areas of Design Control, Change Control and NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing, to ensure development and sustainment of combination product intended for distribution outside the United States complies with applicable regulations and standards. Such devices may include:
- Electro-mechanical and mechanical drug-delivery devices and combination products (e.g. pen injectors, infusion devices)
- Digital Health products classified as stand-alone software medical devices (e.g. apps, websites, web-services)
- Diagnostic devices (e.g. in vitro diagnostics)
You will train and educate key functional partners and management on regional and international medical device requirements, standards and regulations and suggest and participate in improvements to the quality system. Furthermore, you will provide independent review of design for other programs not directly involved in and provide Quality leadership for regulatory interactions for devices in the European market, including on-site inspections.
Amgen Breda, The Netherlands
- BS in Engineering – preferably software, mechanical, or electrical engineering
- 5+ years of Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry
- Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366.
- Knowledge of Medical Device Design Controls, particularly for medical device software development or computerized system validation experience. Experience working with relevant product standards for auto-injectors (11608) and medical electrical equipment (IEC 60601) is a plus.
- Experience in interacting with notified bodies and regulatory agencies, including Amgen EU authorized representative, or Qualified Person (QP) is a plus.
- Strong project management skills including the ability to manage multiple workflows simultaneously and work within business processes as well as quality management systems
- Ability to work in a cross-functional team environment and to influence personnel across functions and at all levels
- High personal integrity with a positive attitude and a strong work ethic
- Experience in driving improvement and implementing change
- Demonstrated the ability to effectively work independently and with individuals located in remote locations
- Inter-personal skills and demonstrated ability to teach lay staff quality principles
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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