Sr Quality Engineer - Physical Methods

Career Category Quality Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Sr. Quality Assurance Engineer  Live What you will do Let’s do this. Let’s change the world. In this vital role you be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.

Co-develop method training materials in partnership with CPO. Ensure activities align with approved budgets and provide evidence-based input for resource needs. Provide quality oversight for the development, maintenance, transfer, and validation of physical test methods, including sample-selection strategies. Provide quality guidance on CPO activities, deliverables, and results. Review and approve protocols and technical reports supporting method development, transfer, validation, and lifecycle management. Advise on technical training materials supporting successful method transfer. Oversee documentation, records, and requirements for in-house and/or outsourced testing laboratories. Review and approve controlled documentation through Veeva-CDOCS. Serve as the QA representative for change controls, CAPAs, non-conformances, and deviations. Support effective CPO method stewardship throughout the method lifecycle. Act as a key advisor and owner for continuous improvement, root-cause analysis, and problem solving. Advise Innovation and Development Leads, site organizations, and Product Quality Leaders. Collaborate with Regulatory partners to support product submissions and related documentation. NOTE: Work third shift to provide primary support for multisite teams. 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 is a [type of person] with these qualifications.

Doctorate degree OR Master’s degree and 4 to 6 years of Quality experience OR Bachelor’s degree and 6 to 8 years of Quality experience OR Diploma and 10 to 12 years of Quality experience Preferred Qualifications: Deep, broad knowledge of quality systems and processes, including change control, risk assessment, and risk management. Quality and manufacturing experience in the biotechnology or medical device industry. Familiarity with combination-product development, including characterization and method design. Working knowledge of applicable combination-product regulations, guidance, and standards, including ISO 14971, ISO 13485, ISO 17025, ICH Q8/Q9/Q10/Q12, EU Annex 1, and 21 CFR Parts 4, 210, 211, and 820. Familiarity with force-measurement equipment, dimensional analysis, calibration practices, and laboratory Good Laboratory Practices (GLP). Experience providing quality oversight for device components. Experience with quality processes and systems, such as TrackWise, Veeva, HLEE. Demonstrated history of supporting or communicating during inspections and audits. Strong problem-solving, troubleshooting, and analytical abilities. Advanced technical-writing skills. Ability to make constructive progress and drive outcomes amid uncertainty or ambiguity. Ability to motivate change,