Quality System Specialist

We anticipate the application window for this opening will close on - 10 Aug 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 Our Cranial & Spinal Technologies (CST) operating unit advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide. Check us out on LinkedIn: Medtronic CST                     In this dynamic role as a Quality Systems Specialist, you will play a key role in supporting the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of quality and performance.

Responsibilities include the following and other duties may be assigned: Support the Corrective and Preventive Actions (CAPA) Program, including root cause investigations, application of analysis tools, action planning, execution, and verification of effectiveness. Prepare and deliver communications, reports, and documentation related to CAPA activities to internal and external stakeholders. Contribute to audit and inspection readiness, support all phases of audits, resolve findings, and serve as liaison with auditors, inspectors, and internal stakeholders. Apply a continuous improvement mindset to enhance quality tools, processes, and overall system effectiveness. Support interpretation of policies, regulations, and standards to ensure full compliance across the organization. Coordinate responses to legal or regulatory requests, including those supporting investigations or litigation. Maintain and update quality assurance programs and policies to reflect evolving standards and best practices. Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office to effectively maintain the Quality Management System. Generates and analyzes standard reports (e.g., Periodic Review, External Standards, Training, and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs. Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP. Must Have (Minimum Requirements) Bachelor's degree with a minimum of 2 years of quality assurance experience in the medical device or pharmaceutical industry, OR a Master's degree with 0 prior experience required.

(Preferred Qualifications) Demonstrated continuous improvement mindset with hands-on experience using quality tools and process improvement methodologies. Strong working knowledge of Quality Management Systems (QMS) compliant with ISO 13485 standards, FDA regulatory, EU MDR, and MDSAP requirements. Proven experience supporting Corrective and Preventive Actions (CAPA), audits, and Change Control Processes. Functional experience in root cause investigation, including application of root cause analysis tools, corrective/preventive action planning, execution, and verification of effectiveness. Proficiency with TrackWise and Agile PLM systems. Familiarity with change management frameworks