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Quality Program Manager , Medical Devices Operational Compliance Center (MD-OCC)
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Quality Program Manager , Medical Devices Operational Compliance Center (MD-OCC)
- Sunnyvale, California, United States
- Sunnyvale, California, United States
Über
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:
- The QPM combines a deep understanding of Project Management, Product Lifecycle, and Quality System Management into a single Technical Program Management role.
- The QPM leads the integration of a product's Regulatory plan, development schedule and MP-QMS requirements into product development milestones.
- The QPM works alongside and supports product TPMs who own Medical Product Lifecycle Plan.
- 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.
- 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.
- The QPM coordinates activities within the project team to address QMS non-conformances.
- 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.
Sprachkenntnisse
- English
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