Senior Quality Engineer

About the role

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 CFR 820.30 and 21 CFR Part 4, CAPA, RCA, 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 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.
• 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 GMP and 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, DFMEA, 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 IQ, OQ, and PQ validation documentation
  • Reviewing and approving process capability studies, SPC programs, DOE; and support troubleshooting of nonconformances, NCRs, and MRB investigations
  • Ensuring compliance with applicable global regulations and quality standards, including ISO 13485, ISO 14971, 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 4 (Combination Products), and GMP
  • Executing CAPA, managing Change Control and Deviations, developing and maintaining SOPs, and driving continuous QMS improvements using Lean and Six Sigma methodologies
  • Utilizing quality documentation systems—including CDOCS, TrackWise, BioConnect, ServiceNow, and Smartsheet—to manage document routing and approval workflows, support document lifecycle activities, ensure proper version control and archival, fulfill vendor and supplier documentation requirements, and review CMO deliverables for compliance
  • Supporting FDA inspections, ISO / MDSAP audits, prepare technical justification packages, and provide documentation and evidence for audit readiness
  • Analyzing quality and engineering data using Minitab for SPC, DOE, and root-cause methodologies (8D, RCA), including reliability trending and statistical evaluations
  • Collaborating with R&D, Regulatory Affairs, QC, Manufacturing, Project Management, suppliers, CMOs, and external partners to support commercial lifecycle management and product quality

Pay

The annual salary for this position in the U.S. is $118,435.00–$140,781.00 per year.

Benefits

• Stock
• Retirement plan
• Medical, dental, and vision coverage
• Life and disability insurance
• Eligibility for an annual bonus (or for sales roles, other incentive compensation)
• Flexible spending accounts
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Schedule

Full Time position.