Principal Quality Engineer - Commercial Quality
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Live
What you will do
Lets do this! Lets change the world!
Accountable to ensure quality and compliance associated with Amgen products, to develop, maintain, and continuously improve the medical device/combination product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new commercial 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 teams, employ quality principles and companys procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development of final product align with dynamic global regulations and standards.
Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs.
Train and educate key functional partners and management on combination product requirements, standards and regulations
Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of commercial programs
Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories.
Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging.
Provide independent design review for other programs
Ensure inspection readiness and maintain CE marks for existing combination product 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 Final Product Technologies Quality (FPTQ) 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 devices and combination products
Train and mentor relevant staff for development and succession planning
Assure that current regulatory requirements and trends are integrated into the capability
Advise and guide product teams as Quality representative
Review and approve combination product device design control and post-commercial documentation (internally and at times, externally)
Interface with regulators and Notified Bodies
Review and approve procedures and work instructions
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications:
Doctorate degree and 2 of professional experience Program Management, Operational Excellence, Quality, R&D, Production
Masters degree and 6 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
Bachelors degree and 8 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
Associates degree and 10 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
High school diploma / GED and 12 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
Bachelors or Masters degree in Life sciences, Engineering, or related subject area
7 years of professional experience in Program Management, Operational Excellence, Quality, R&D, and/production
Deep medical device/combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects move through design controls
Subject matter expert in Risk Management for combination products
Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
Strong project management skills / ability to lead all aspects of numerous projects simultaneously
Deep understanding of cGxP regulations, practices, and trends pertaining to medical device/combination product 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
Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
Advanced technical writing 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%
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
#OperationsEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.