Quality Program Manager , Medical Devices Operational Compliance Center (MD-OCC)
Amazon.com Services LLC•3h ago
United StatesOnsiteFull-timeManager Level5+ yrs exp
H-1B verified · 2310 LCAs
Top focus
Program ManagerTechnical Program Manager
- Amazon Devices, and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and devices like Fire tablets, Fire TV, and Echo Frames. 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. About the team The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems
- enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
- Experience reading and writing procedures, technical documents
- 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
- 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)
- 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) Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff
- adhere to standards of excellence despite stressful conditions
- communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service
- and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner. 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
Required skills
Project ManagementProduct LifecycleQuality System ManagementRegulatory ComplianceBiocompatibilitySterilizationSoftwareHardwareAssayISO 13485ISO 14971Data & AIAI/MLAnalyticsDatabase