Quality Systems Manager

A Day in the Life

Medtronic's Acute Care & Monitoring (ACM) business develops technologies that help clinicians monitor patients, identify changes in their condition, and make informed decisions across the continuum of care. The Quality Systems Manager will provide leadership and oversight for Quality Systems activities supporting the ACM organization across its product portfolio and global sites.

This role will lead a team of Quality Engineers and Quality Systems Specialists responsible for key Quality Management System activities, including CAPA management, audit and inspection management, training administration, management reviews, procedure implementation, and ongoing Quality System compliance. This individual will serve as a key Quality Systems partner to cross-functional stakeholders across Regulatory, Operations, R&D, Change Management, and Enterprise Quality Systems.

Primary Responsibilities

• Provides leadership and oversight for the development, implementation, and maintenance of Quality System programs, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and applicable standards.
• Leads and develops a team of Quality Engineers and Quality Systems Specialists responsible for supporting Quality System activities across the operating unit.
• Provides oversight of the CAPA program, partnering with CAPA owners to ensure investigations are thorough, corrective and preventive actions are appropriate, and CAPAs progress effectively and within established timelines.
• Provides expertise and guidance in interpreting Quality System policies, regulatory requirements, standards, and internal procedures to support ongoing compliance across the organization.
• Leads audit and inspection readiness, preparation, and execution, including coordination of audit activities, engagement with internal subject matter experts, and communication with auditing groups and inspectors.
• Oversees the resolution and timely closure of audit and inspection findings, including ensuring appropriate ownership, response plans, corrective actions, and follow-up activities are established and completed.
• Partners directly with operating entities and cross-functional stakeholders to assess Quality System processes, identify areas for improvement, and ensure requirements are consistently implemented.
• Leads and supports periodic management reviews by coordinating stakeholder inputs, reviewing Quality System performance and metrics, developing management review content, and presenting information to organizational leadership.
• Oversees implementation of new or revised enterprise Quality System procedures and requirements, ensuring the operating unit evaluates changes and effectively incorporates applicable requirements into its processes.
• Provides oversight for Quality System training administration, procedure implementation, periodic reviews, and other activities necessary to maintain an effective and compliant Quality Management System.
• Monitors Quality System performance, trends, KPIs, and compliance activities to identify risks, improvement opportunities, and areas requiring additional support or training.
• Leads or supports Quality System improvement initiatives and special projects.
• Promotes consistent Quality System standards and best-practice sharing across the organization while fostering a culture of quality, accountability, collaboration, and continuous improvement.

Required Qualifications

• Bachelors degree with 5 years of relevant experience OR Masters degree with 3 years of relevant experience
• Direct CAPA experience
• Strong audit management experience, ideally having directly run audits
• Working knowledge of applicable medical device regulations, standards, and Quality Systems requirements

Preferred Qualifications

• FDA inspection or Notified Body auditing experience
• Medical device or pharmaceutical industry experience
• People leadership experience