Principle Quality Engineer - Development Quality

The Principal Quality Engineer - Development Quality is accountable for advice to, and oversight of, technical aspects in design control, and transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of combination and non-combination products associated with Final Product Technologies activities.

Key Responsibilities

• Accountable for ensuring that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities.
• Attend development program meetings as required as part of program working teams.
• Work cross-functionally with individuals and project teams to ensure success of development project efforts.
• Provide guidance on documentation structures created during development activities.
• Identify proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable regulations and Amgen Procedures.
• Provide input to the Design and Development Plans for projects, and review and approve relevant combination product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated projects.
• Actively participate and contribute to applicable Design Control Phase Design Reviews.
• Provide Quality oversight of Design Characterization and Verification and Validation activities.
• Ensure adherence to all relevant regulations and standards based on the type of device under development.
• Represent FPTQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of supplier qualification and development as it relates to design control activities.
• Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses. Participates in audits and inspections, is well prepared by owning relevant details that are supported by evidence and for associated projects.
• Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
• Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s).
• 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.
• Represents FPTQ at TCP or External Engagement initiatives as necessary. Acts as delegate for head of FPTQ Development Quality as needed.

Basic Qualifications

Doctorate degree and 2 years of Quality experience

OR

Master's degree and 6 years of Quality experience

OR

Bachelor's degree and 8 years of Quality experience

OR

Associate's degree and 10 years of Quality experience

OR

High school diploma / GED and 12 years of Quality experience

Preferred Qualifications

• 7+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor's degree in a Science field
• Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
• Deep combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter into design controls
• Strong knowledge of quality engineering and device engineering
• Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
• Strong problem solving, trouble shooting, and analytical skills
• Advanced technical writing skills
• Able to balance complexity between innovation and regulation
• Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
• Constructively progress to outcomes despite uncertainty or ambiguity
• Drive change, efficiency, and strong cross-functional relationships
• Excellent verbal and written communication
• Ability to drive continuous improvements
• Ability to Influence and demonstrate strong command / seen as owner of their program
• Excellent communication to all levels of the organization
• Supervisory skills and/or demonstrated ability to lead without direct authority
• Experience driving decision making by using DAI principles
• Able to manage resources
• Able to apply strategic and critical thinking
• Able to perform with a Global mindset
• Ability to travel +/- 15-20% of time to domestic and international Amgen sites

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.