Senior Quality Engineer

Senior Quality Engineer

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Duties:
Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Combination Product Operations activities;
Ensure that the Quality Systems in place for Amgen products are appropriately scoped and followed;
Provide quality oversight for device and combination-product related design controls per FDA (Food and Drug Administration) CFR (Code of Federal Regulations) 820.30 and 21 CFR Part 4, CAPA (Corrective and Preventative Actions), RCA (Root Cause Analysis), Change Controls, product complaints investigations, and other assignments as given;
Manage low to moderate complexity programs such as automating team activities and combination product commercial quality oversight with minimal supervision;
Collaborate with the Senior Manager Quality Engineering, COPQ (Combination Product Operations Quality) Commercial and be a liaison with other groups in Amgen as needed to support programs; and Provide quality guidance for documentation associated with device and combination product activities. May telecommute.

Requirements:
Master's degree (or foreign equivalent) in Industrial and Systems Engineering, Bioengineering, Mechanical Engineering, or a related field and 3 years of experience in the job offered or in a quality-related occupation. Position requires 3 years of experience in the following:

• Owning and managing Design History Files, Design Trace Matrices, Control Plans, and design documentation for commercial medical devices and combination products;
• Providing Quality review and approval for both Good Manufacturing Practices (GMP) and non-Good Manufacturing Practices (non-GMP) technical records to ensure compliance with regulatory and internal requirements;
• Leading and executing quality oversight for Design Verification & Validation (V&V) activities, including protocol development, test execution oversight, data analysis, statistical evaluations, and final reporting;
• Performing Quality review of technical design documentation, including drawings, specifications, requirements, protocols, and reports, to support compliant design and commercialization of medical devices and combination products;
• Reviewing and approving Risk Management Files per ISO 14971, including hazard analysis, Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), usability risk assessments, and risk evaluations for changes and deviations for drug-device combination products;
• Providing Quality oversight for commercialized drug delivery systems by supporting reliability modeling, performance trending, engineering studies, and design transfer activities;
• Reviewing and approving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation documentation;
• Reviewing and approving process capability studies, Statistical Process Control (SPC) programs, Design of Experiments (DOE); and support troubleshooting of nonconformances, Nonconformance Reports (NCRs), and Material Review Board (MRB) investigations;
• Ensuring compliance with applicable global regulations and quality standards, including ISO 13485, ISO 14971, 21…