Quality Systems Manager

Preferred Qualificationsnice to have

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

• Promote an inclusive, accountable, responsive, and continuous- improvement culture

• 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.

• Health, dental and vision insurance

• 401(k) with employer contribution and match

• Paid time off

• Employee Stock Purchase Plan

• Tuition assistance

• Medtronic Incentive Plan (MIP)