Quality Systems Specialist

We anticipate the application window for this opening will close on - 27 Jul 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** At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. In this role as a Quality Systems Specialist, you will support the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory requirements. You will assist in audit readiness activities, support Quality Management System (QMS) processes, and contribute to continuous improvement initiatives. You will support internal and external audits, including FDA inspections, Notified Body audits, and other regulatory inspections, helping to maintain a state of inspection readiness and compliance. The Quality Systems Specialist supports the development, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and company requirements. This role partners with cross-functional teams to support audits and inspections, CAPA and compliance activities, Quality Management Reviews, Operations Quality Walks, SAP QM administration, and quality system improvement initiatives while helping maintain a state of inspection readiness and regulatory compliance. **Key Responsibilities** - Support the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance. - Interpret and apply internal policies, regulatory, and governmental requirements with guidance from quality leadership. - Collaborate with cross-functional teams to perform process analysis and support adherence to applicable regulations. - Support internal and external audit and inspection activities, including audit preparation, documentation, response coordination, and follow-up of observations. - Assist as a point of contact during audits and inspections, ensuring timely communication and document retrieval. - Prepare quality reports, metrics, and documentation, including CAPAs and quality records. - Support requests related to regulatory, legal, or compliance matters as needed. - Maintain and update quality assurance programs, procedures, and policies. - Participate in continuous improvement initiatives and promote best practice sharing across functions. **QMS Governance & Regulatory Expertise:** Support the Quality Management System by assisting with implementation and maintenance of regulatory requirements, including but not limited to FDA 21 CFR Part 820, ISO 13485, and applicable company procedures. Support QMS harmonization efforts and compliance activities. **Audit & Inspection Leadership:** Coordinate and support internal and external audits and inspections by assisting with planning, document collection, audit logistics, and follow-up activit…