Quality Systems Director

At MiniMed, quality is at the heart of our commitment to improving the lives of people living with diabetes. We're looking for a Quality Systems Director to provide enterprise leadership and strategic oversight of our global Quality Management System, strengthening governance, regulatory compliance, and organizational effectiveness across MiniMed. In this highly visible leadership role, you'll drive QMS strategy, harmonization, training governance, and continuous improvement while partnering with senior leaders across the organization to identify emerging risks, and build scalable quality systems that support our business and the patients we serve.

Responsibilities

Leads MiniMed Quality Management System framework ensuring effective governance, regulatory compliance, and executive oversight across all MiniMed Quality Management Systems; Establishes and monitors mechanisms to evaluate QMS effectiveness, identify systemic risks, measure performance, and drive continual improvement across global quality organizations; Directs the global quality training governance program, establishing competency, qualification, and training effectiveness requirements; Provides strategic oversight of QMS change management processes; Leads QMS assessments of emerging and revised regulatory requirements, standards, and industry expectations; Drives harmonization, simplification and alignment of quality system requirements, governance models, and best practices across global sites and QMS entities; Leads development of quality objectives, quality system metrics and executive reporting mechanisms; Ensures ongoing inspection and audit readiness for the QMS processes in scope and provides executive leadership during regulatory inspections and audits; Chairs or leads cross-functional governance forums related to Management Controls, QMS effectiveness, training governance, and quality system maturity; Leads and develops a global Quality Systems organization, ensuring adequate resources, capability development, succession planning, and operational excellence

Requirements

Bachelors Degree with 10+ years of quality systems experience and 7+ years experience in people management OR Advanced Degree with 8+ years of quality systems experience and 7+ years experience in people management

Nice to have

Previous experience leading Quality Systems Teams within medical device industry; Experience with leading and supporting FDA auditing; Previous PMS experience; Experience leading large organizations in strategy and execution of quality systems; Previous experience developing global quality systems strategy

Benefits

Competitive salary and flexible benefits package; Short-term incentive (STI); Annual long-term incentive plan; Health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; Life insurance; Long-term disability leave; Dependent daycare spending account; Incentive plans; 401(k) plan with company match; Short-term disability coverage; Paid time off and holidays; Employee Stock Purchase Plan; Employee Assistance Program; Non-qualified Retirement Plan Supplement; Capital Accumulation Plan