Principal Quality Engineer, Digital Focus

Description

Accountable to ensure quality and compliance associated with Amgen software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches.

Key Responsibilities

• As the Quality Engineering representative on cross-functional digital health product teams, employ quality principles and companys procedures including but not limited to the areas of good software engineering, medical device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development of digital health product complies with regulations and standards while accommodating Agile software development methodology.
• Train and educate key functional partners and management on medical device and digital health product requirements, standards and regulations
• Plan and lead continuous improvements to the SaMD quality processes
• Provide independent design review for other software medical device programs
• Ensure inspection readiness and maintain CE marks for existing software medical devices
• Conduct investigations, root cause analyses and risk assessments
• Collaborate cross-functionally and with Senior Management to drive improvements and provide backup support to other Quality focus areas
• Work in partnership with Digital Health and Diagnostic Quality (DHDQ) Leadership to develop business plans that cultivate staff development and support the direction of the business
• Benchmark with industry regarding quality and compliance models for software medical devices and digital health products
• Train and mentor relevant staff for development and succession planning

Basic Qualification:

Doctorate degree and 2 years ofMedical Device, IS IT, Quality and/or Engineering experience
OR
Masters degree and 6 years of Medical Device, IS IT, Quality and/or Engineering experience
OR
Bachelors degree and 8 years ofMedical Device, IS IT, Quality and/or Engineering experience
OR
Associates degree and 10 years of Medical Device, IS IT, Quality and/or Engineering experience
OR
High school diploma / GED and 12 years of Medical Device, IS IT, Quality and/or Engineering experience

Preferred Qualifications:

• Bachelors or Masters degree in Life sciences, Engineering, IS, or related subject area
• 7 years of professional experience in Program Management, Operational Excellence, Quality, R&D, and/coproduction
• Direct software medical device/digital health experience
• Deep experience with software medical device quality and compliance concepts
• Strong project management skills / ability to lead and/or lead all aspects of numerous projects simultaneously
• Deep understanding of cGxP regulations, practices, and trends pertaining to medical device quality
• Lean six-sigma greenbelt/blackbelt
• Demonstrated strong leadership, negotiation and influencing skills along with advanced communication and analytical skills
• Effective and timely decision making and influencing skills
• Executive management communication experience
• Willingness to learn and be persistent
• Ability to adapt to changing business needs
• Willing and able to travel up to 20%

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.