Role OverviewThe 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. This role combines project management, product lifecycle, and quality system management into a single technical program management role.
What You Will Do
The QPM will lead the integration of a product's regulatory plan, development schedule, and MP-QMS requirements into product development milestones. They will work alongside product TPMs, collaborate with functional experts, and ensure QMSR program requirements are identified, clarified, implemented, and met.
Why It Might Be a Fit
The QPM will be responsible for owning the regulated quality system aspects of the product development plan, leading the technical, quality, and regulatory compliance pathway. They must be able to identify potential risks or obstacles, understand technical risks, and propose solutions to complex problems in a cross-functional environment.
Requirements
- Experience reading and writing procedures, technical documents, and engineering drawings
- 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)
Benefits
- Health insurance (medical, dental, vision, prescription)
- Basic Life & AD&D insurance
- 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
- Parental leave
- Sign-on payments
- Restricted stock units (RSUs)
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