Sr. Quality Systems Manager

About the Role

At MiniMed, quality is at the heart of our commitment to improving the lives of people living with diabetes. We're looking for a Sr. Quality Systems Manager to lead the MiniMed CAPA program that will impact the entire organization. In this role, you'll own the CAPA process and strategy that support our business and the patients we serve.

Responsibilities

• Leads the MiniMed Corrective and Preventive Action (CAPA) program, establishing governance, standards, procedures, and oversight mechanisms to ensure consistent implementation and regulatory compliance across all MiniMed QMS entities.
• Establishes and monitors CAPA effectiveness metrics, trend analyses, and performance indicators to evaluate the health of the CAPA program, identify systemic quality risks, and drive continuous improvement.
• Provides governance and oversight for CAPAs with enterprise impact, ensuring issues affecting the global MiniMed QMS are appropriately assessed, escalated, approved, and monitored through closure.
• Partners with site and QMS entity CAPA Review Boards to ensure consistent application of CAPA requirements, effective root cause analysis, risk-based decision making, and alignment of remediation activities across QMS entities.
• Establishes and maintains inspection readiness strategies for the CAPA process, ensuring CAPA documentation, justifications, timelines, and evidence packages support successful regulatory inspections and third-party audits.
• Drives enterprise accountability for CAPA timeliness and compliance by establishing performance expectations, monitoring overdue activities, and ensuring risk-based rationale and executive visibility for extension requests and delayed actions.
• Leads identification and escalation of systemic quality and compliance risks emerging from CAPA activities, partnering with Quality, Regulatory Affairs, and business leadership to drive timely resolution.
• Develops CAPA performance dashboards and executive reporting mechanisms that provide visibility into program effectiveness, compliance trends, recurring issues, inspection risks, and emerging quality concerns.
• Leads and develops the MiniMed CAPA organization, ensuring appropriate capability, resource planning, process expertise, and continuous improvement to support enterprise quality objectives.
• Drive the adoption and governance of AI solutions within CAPA processes to improve trend analysis, risk identification, investigation effectiveness, and continuous improvement outcomes.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelors Degree with 7+ years of quality systems experience and 5+ years experience in people management OR Advanced Degree with 5+ years of quality systems experience and 5+ years experience in people management

Nice To Have

• Ability to evaluate, implement, and govern AI-enabled solutions within Quality Management Systems while balancing innovation, compliance, data privacy, and patient safety considerations.
• Previous experience leading Quality Systems Teams within medical device industry
• Experience with leading and supporting FDA inspections, other agencies and notified body audits
• Experience leading large organizations in strategy and execution of quality systems
• Previous experience developing global quality systems strategy
• Previous experience on remediation efforts in medical device industry considerations.