Quality Systems Director
About The Position
The Quality Systems Director provides enterprise leadership and strategic oversight of MiniMed’s global Quality Management System (QMS), strengthening governance, regulatory compliance, and organizational effectiveness. The role leads QMS strategy, harmonization, training governance, and continuous improvement, and partners with senior leaders to identify emerging risks and build scalable quality systems that support the business and people living with diabetes. The director leads and develops a global Quality Systems organization responsible for MiniMed governance processes, including capability development, succession planning, resource adequacy, and operational excellence. The role also provides executive leadership during regulatory inspections and audits involving QMS processes in scope.
Requirements
- Bachelor’s degree and at least 10 years of quality systems experience, plus at least 7 years of people-management experience; OR an advanced degree and at least 8 years of quality systems experience, plus at least 7 years of people-management experience.
Nice To Haves
- Previous experience leading Quality Systems teams within the medical device industry.
- Experience leading and supporting FDA auditing.
- Previous PMS experience.
- Experience leading large organizations in quality-systems strategy and execution.
- Previous experience developing global quality-systems strategy.
Responsibilities
- Lead MiniMed’s Quality Management System framework, ensuring effective governance, regulatory compliance, and executive oversight across its QMS entities.
- Establish and monitor mechanisms to evaluate QMS effectiveness, identify systemic risks, measure performance, and drive continual improvement across global quality organizations.
- Direct global quality training governance, including competency, qualification, and training-effectiveness requirements, and promote consistent implementation across QMS entities.
- Provide strategic oversight of QMS change management, ensuring significant changes are assessed, approved, communicated, and implemented across impacted organizations.
- Lead assessment of emerging and revised QMS regulatory requirements, standards, and industry expectations, ensuring timely implementation and aligned quality-system controls.
- Drive harmonization, simplification, and alignment of quality-system requirements, governance models, and best practices across global sites and QMS entities.
- Lead the development of quality objectives, quality-system metrics, and executive reporting on QMS performance, compliance status, emerging risks, and organizational effectiveness.
- Ensure ongoing inspection and audit readiness for QMS processes in scope and provide executive leadership during related regulatory inspections and audits.
- Chair or lead cross-functional governance forums for Management Controls, QMS effectiveness, training governance, and quality-system maturity.
- Lead and develop the global Quality Systems organization, ensuring adequate resources, capability development, succession planning, and operational excellence.
Benefits
- Competitive salary and flexible benefits package.
- Health, dental, and vision insurance.
- Health Savings Account and Healthcare Flexible Spending Account.
- Life insurance and long-term disability leave.
- Dependent daycare spending account.
- Incentive plans, including short-term incentives and an annual long-term incentive plan.
- 401(k) plan with company match.
- Short-term disability coverage.
- Paid time off and holidays.
- Employee Stock Purchase Plan.
- Employee Assistance Program.
- Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Director
