Full Job Description
Working as part of the Medical Devices Operational Compliance Team, the Quality Program Manager will engage cross-functionally to ensure the quality management system is operating effectively to exceed customer expectations, while meeting the regulatory requirements.
Key job responsibilities
o The QPM combines a deep understanding of Project Management, Product Lifecycle, and Quality System Management into a single Technical Program Management role.
o The QPM leads the integration of a product's Regulatory plan, development schedule and MP-QMS requirements into product development milestones.
o The QPM works alongside and supports product TPMs who own Medical Product Lifecycle Plan.
o During NPI, the QPM is accountable for the MP-QMS Plan of Record. The QPM collaborates with functional experts in the organization (e.g. Biocompatibility, Sterilization, Logistics, Software, Hardware, Assay etc.) to ensure QMSR program requirements are identified, clarified, implemented both procedurally and in the product through protocol development, testing and compliance.
o The QPM is accountable to ensure proper records and reports are created and stored according to records, and reporting SOPs, as well as are accountable to ensure projects adhere to QMSR Design Controls requirements and business product lifecycle stages.
o The QPM coordinates activities within the project team to address QMS non-conformances.
o The QPM may also be required to perform document control responsibilities depending on the program needs.
A day in the life
The Quality Program Manager owns the Regulated Quality System aspects of the Product Development Plan, leading the Technical, Quality, and Regulatory Compliance Pathway. You must be able to identify potential risks or obstacles, understand technical risks, able to propose solution to complex problems with ambiguous information and moderate direction in a cross functional environment. You will be responsible for owning actions to resolve problems.
BASIC QUALIFICATIONS
- Experience reading and writing procedures, technical documents, and engineering drawings, or experience in requirement gathering and ability to write clear and detailed requirement document
- Experience collaborating with cross-functional teams
- Familiarity with the US Food and Drug Administration (FDA) regulations-specifically 21 CFR Part 820
- Foundational understanding of the ISO 13485 standard for medical device QMS
- Knowledge of ISO 14971, which governs the application of risk management to medical devices
- Ability to analyze non-conformances, investigate them and use statistical data to troubleshoot issues
- Bachelor's Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
PREFERRED QUALIFICATIONS
- Experience working with Data & AI related technologies, including, but not limited to, AI/ML, GenAI, Analytics, Database, and/or Storage
- Pursuing conventional quality certifications, such as a Certified Quality Engineer (CQE) through the American Society for Quality (ASQ)
The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
USA, CA, Sunnyvale - 109,600.00 - 185,000.00 USD annually
