Principal Quality Systems Specialist
About The Position
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.
Requirements
- Bachelor degree in a related field minimum of 7 years of related experience
- Advanced degree with minimum of 5 years of related experience
- PHD with 3 years of related experience
Nice To Haves
- 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 managing 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 and document control processes.
- Excellent communication (verbal and written), critical thinking, interpersonal, organizational, time management, and presentation skills.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and collaboratively within teams and across functions.
Responsibilities
- 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 regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
