We anticipate the application window for this opening will close on - 9 Jun 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

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.

Join our collaborative team at our manufacturing site in Plymouth, MN to put our patients first through ensuring compliance in everything we do. In this role as a Senior Quality Systems Specialist, you will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements. You also will provide guidance and mentorship on CAPA processes and tools, such as root cause analysis, and participate in both internal and external audits and inspections. Additionally, you will support the Quality Management System by performing continuous improvement activities and ensuring that processes are compliant to regulations as well as meeting the needs of site Operations.

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

• Participate in the development and maintenance of quality programs, systems, processes and procedures that ensure compliance to established internal and external standards and guidelines.

• Provide expertise and guidance in interpreting internal policies and procedures, as well as external standards, regulations, and country requirements to ensure compliance.

• Assist in monitoring Corrective and Preventative Actions (CAPAs) for rigor and timeliness, as well as mentoring root-cause analysis sessions and change-impact assessments using a variety of problem-solving techniques.

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

• Prepares metrics and report-outs and provides to applicable stakeholders.

• Engage in the development of management presentations, including driving participants to provide timely metrics and escalations.

• Coordinate Enterprise-initiated changes with impacted departments to identify and make required changes to site documentation for compliance.

• Ensure the quality assurance programs and policies are maintained and modified per periodic review requirements or project needs.

• Work cross-functionally to provide guidance on the development and maintenance of quality plans to track quality-impacting projects.

• Manage projects, as assigned, for appropriate scoping, cross-functional resourcing, and timeliness, with consideration, escalation, and resolution for quality impacts

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. 

• Bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry

Nice to Have

• QMS experience, with knowledge of ISO 13485, EU MDR, and FDA CFR preferred

• Experience with CAPA and Root Cause Analysis tools

• Ability to set up and support internal and external audits, and coordinate responses and resolutions to findings

• Agile and Trackwise systems knowledge

• Strong capabilities with PowerPoint, Word, and Excel

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. C