Careers that Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as a Sr. Quality Systems Manager in Cardiac Surgery (CS), you will lead a team of QMS specialists responsible for maintaining the Cardiac Surgery QMS and integration new business acquisition(s) into the Medtronic Cardiac Surgery operating unit.

This role is responsible for key activities including Quality Management Review, CAPA process oversight, standards management execution, audit leadership and support, and overall compliance of the Medtronic Quality Management System with FDA regulations, ISO standards, corporate policy, and other applicable regulations.

Cardiac Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this Operating Unit provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies:

• Surgical heart valves

• Cardiac OR solutions (e.g., blood management, cannulae)

• Extracorporeal life support

• Coronary artery bypass grafting (CABG) solutions

A Day in the Life

Primary Responsibilities

• 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.

This position would be required to sit onsite at 8200 Coral Sea Street NE Mounds View, MN 55112 with the possibility of working 2 days remote per week.

Required Qualifications

• Bachelors degree
• Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience

Preferred Qualifications

• Medical Device experience
• Experience with quality systems and/or regulatory
  
  

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)