Quality Program Manager , Medical Devices Operational Compliance Center (MD-OCC)

About the role

The Quality Program Manager (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 Technical Program Managers (TPMs) who own Medical Product Lifecycle Plans.

Responsibilities

• Combines a deep understanding of Project Management, Product Lifecycle, and Quality System Management into a single Technical Program Management role.
• Led the integration of a product’s Regulatory plan, development schedule, and MP-QMS requirements into product development milestones.
• Works alongside and supports product TPMs who own Medical Product Lifecycle Plan.
• During New Product Introduction (NPI), the QPM is accountable for the MP-QMS Plan of Record. 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.
• Accountable to ensure proper records and reports are created and stored according to records and reporting SOPs, as well as ensuring projects adhere to QMSR Design Controls requirements and business product lifecycle stages.
• Coordinates activities within the project team to address QMS non-conformances.
• May also be required to perform document control responsibilities depending on the program needs.

Qualifications

• Experience reading and writing procedures, technical documents, and engineering drawings, or experience in requirement gathering and ability to write clear and detailed requirement documents.
• 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 a scientific discipline, such as Biomedical Engineering, life sciences, biology (or equivalent qualifications).