At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most.

Responsibilities may include the following and other duties may be assigned.

Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe.

Check us out on LinkedIn: Medtronic CST

In this dynamic role as a Senior Quality System Specialist, you will play a key role in overseeing 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:

• Drive the strategy and design of 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.

• Drive audit and inspection readiness—manage all phases of audits, resolve findings, and serve as liaison with auditors, inspectors, and internal stakeholders

• Develop strategies and plans for continuous improvement to enhance quality tools, processes, and overall system effectiveness.

• Provide expert 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.

• Develop strategies and plans for 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

• Partners with Quality System Program Manager on the development, generation and analysis of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

• Co-ordinates legal requests in support of government investigations or litigations.

• Ensures the quality assurance programs and policies are maintained and modified regul