Senior CAPA Specialist

We anticipate the application window for this opening will close on - 12 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.

Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Supporting both the Rice Creek and Cheshire Plymouth manufacturing facilities, this role is part of a Quality organization focused on ensuring the safety, quality, and reliability of pharmaceutical products delivered to patients worldwide. The Quality function partners closely with manufacturing, operations, and compliance teams to maintain effective quality systems, drive continuous improvement, and ensure adherence to internal standards and regulatory requirements.

This position is based onsite at the Rice Creek facility in Fridley, Minnesota, with responsibility for supporting CAPA portfolios across both Rice Creek and Plymouth Cheshire. Onsite presence is required five (5) days per week to support operations, quality system activities, and cross-functional collaboration. Some travel between sites is expected. The Senior CAPA Specialist leads and maintains Corrective and Preventive Action (CAPA) activities within the Quality Management System for the Rice Creek and Plymouth Cheshire facilities.

This role partners with manufacturing, quality, and operational teams to drive timely investigations, effective root cause analysis, documentation, reporting, and closure of quality system records. The position plays a key role in maintaining regulatory compliance, strengthening quality system effectiveness, and advancing continuous improvement initiatives across both sites.

• Lead CAPA activities from initiation through effectiveness verification and closure.
• Review investigations, root cause analyses, and corrective action plans for quality system compliance and effectiveness.
• Provide guidance on quality system requirements, regulatory expectations, and CAPA best practices.
• Partner with manufacturing and functional teams to identify process improvements and drive sustainable corrective actions.
• Monitor CAPA metrics, trends, and reporting to identify compliance risks and improvement opportunities.
• Support internal audits, regulatory inspections, and audit readiness activities, including response development and closure of observations.
• Prepare, review, and maintain quality records, reports, and documentation in accordance with established procedures.
• Mentor team members and provide support for projects related to quality system performance and compliance.

• Bachelor's degree with 4+ years of experience OR Master's degree with 2+ years of experience in Quality, Manufacturing, Engineering, Life Sciences, or a related regulated environment.
• Experience managing Corrective and Preventive Action (CAPA) processes within a regulated industry.
• Experience conducting root cause investigations and developing corrective action plans.
• Experience interpreting and applying quality system requirements, procedures, and regulatory standards.
• Experience working cross-functionally to drive issue resolution and process improvements.
• Experience with in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Experience supporting regulatory inspections and internal or external audits.
• Knowledge of Quality Management Systems (such as Track Wise) and quality compliance frameworks.
• Exper…