Senior Quality Engineer

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
• Provide quality guidance for documentation associated with device and combination product activities

Requirements

• Masters 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
• Experience owning and managing Design History Files, Design Trace Matrices, Control Plans, and design documentation for commercial medical devices and combination products
• Experience 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
• Experience 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
• Experience 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
• Experience 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 Good Manufacturing Practices (GMP)
• Responsibilities include executing Corrective and Preventive Actions (CAPA), managing Change Control and Deviations, developing and maintaining Standard Operating Procedures (SOPs), and driving continuous Quality Management System (QMS) improvements using Lean and Six Sigma methodologies
• Experience 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 Contract Manufacturing Organization (CMO) deliverables for compliance
• Experience supporting Food and Drug Administration (FDA) inspections, International Organization for Standardization (ISO) / Medical Device Single Audit Program (MDSAP) audits, preparing technical justification packages, and providing documentation and evidence for audit readiness
• Experience analyzing quality and engineering data using Minitab for Statistical Process Control (SPC), Design of Experiments (DOE), and root-cause methodologies (8 Disciplines (8D), Root Cause Analysis (RCA)), including reliability trending and statistical evaluations
• Experience collaborating with Research and Development (R&D), Regulatory Affairs (RA), Quality Control (QC), Manufacturing, Project Management, suppliers, Contract Manufacturing Organizations (CMOs), and external partners to support commercial lifecycle management and product quality

Qualifications

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Skills

Experience owning and managing Design History Files, Design Trace Matrices, Control Plans, and design documentation for commercial medical devices and combination products

Experience 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

Experience 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

Experience 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

Experience 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 Good Manufacturing Practices (GMP)

Experience executing Corrective and Preventive Actions (CAPA), managing Change Control and Deviations, developing and maintaining Standard Operating Procedures (SOPs), and driving continuous Quality Management System (QMS) improvements using Lean and Six Sigma methodologies

Experience 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 Contract Manufacturing Organization (CMO) deliverables for compliance

Experience supporting Food and Drug Administration (FDA) inspections, International Organization for Standardization (ISO) / Medical Device Single Audit Program (MDSAP) audits, preparing technical justification packages, and providing documentation and evidence for audit readiness

Experience analyzing quality and engineering data using Minitab for Statistical Process Control (SPC), Design of Experiments (DOE), and root-cause methodologies (8 Disciplines (8D), Root Cause Analysis (RCA)), including reliability trending and statistical evaluations

Experience collaborating with Research and Development (R&D), Regulatory Affairs (RA), Quality Control (QC), Manufacturing, Project Management, suppliers, Contract Manufacturing Organizations (CMOs), and external partners to support commercial lifecycle management and product quality

Benefits

Amgen offers a comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models, including remote and hybrid work arrangements, where possible