We anticipate the application window for this opening will close on - 24 Oct 2025

 

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

Medtronic’s Cranial and Spinal Technologies (CST) Operating Unit is committed to transforming patient care through groundbreaking innovations in neurosurgery and spinal procedures. Our comprehensive portfolio includes spinal implants, robotics-assisted surgical solutions like the Mazor™ Robotic Guidance System, StealthStation™ surgical navigation, and biologics for bone healing, all designed to enhance surgical precision, efficiency, and patient outcomes. Beyond technology, we support surgeons through education, training, and clinical research, ensuring they have the tools and knowledge to achieve the best possible results. By continuously driving innovation and collaboration, Medtronic is redefining cranial and spinal care, improving lives worldwide.​​

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

#Neuroscience

Careers That Change Lives

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 may include the following and other duties may be assigned.

• Lead 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 the primary liaison with auditors and inspectors.

• Apply a continuous improvement mindset to enhance quality tools, processes, and overall system effectiveness.

• Provide expert interpretation of policies, regulations, and standards to ensure full compliance across the organization.

• Partner with operational teams to deliver ongoing process analysis and compliance oversight.

• 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.

• Promote consistency and best-practice sharing across global operations, advancing the company’s mission and quality excellence worldwide.

Location: Fort Worth, TX

• This is an onsite position located in Fort Worth, Texas.

Ability to travel up to: N/A

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree required with a minimum of 4 years of Quality tools and Process Improvement experience

• OR advance degree with a minimum of 2 years of Quality tools and Process Improvement experience

Nice to Have (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.

• Familiarity with Quality Management System Regulation (QMSR) and applicable FDA regulatory requirements.

• Basic understanding of EU MDR and MDSAP requirements.

• Proven experience managing Corrective and Preventive Actions (CAPA), audits, and Change Control Processes.

• Functional expertise in root cause investigation, including application of root cause analysis tools, corrective/prevent