Career CategoryQuality
Job DescriptionSenior Quality EngineerDuties: 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:
1. Owning and managing Design History Files, Design Trace Matrices, Control Plans, and design documentation for commercial medical devices and combination products;
2. 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;
3. 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;
4. 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;
5. 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;
6. Providing Quality oversight for commercialized drug delivery systems by supporting reliability modeling, performance trending, engineering studies, and design transfer activities;
7. Reviewing and approving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation documentation;
8. 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;
9. 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);
10. 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;
11. 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;
12. Supporting Food and Drug Administration (FDA) inspections, International Organization for Standardization (ISO) / Medical Device Single Audit Program (MDSAP) audits, prepare technical justification packages, and provide documentation and evidence for audit readiness;
13. 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; and
14. 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.
Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-244950
Job type: Full Time position. The annual salary for this position in the U.S. is $118,435.00-$140,781.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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
Apply now and make a lasting impact with the Amgen team. careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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