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

Position Summary

This role is responsible for leading and executing Quality Systems and Regulatory Compliance activities to ensure sustained compliance with global regulations, Medtronic Quality Management System (MQS) requirements, and internal policies. The position partners cross‑functionally to drive continuous improvement, risk mitigation, and a culture of quality and compliance.

Key Responsibilities:
Lead the execution and continuous improvement of Quality System processes, projects, and initiatives in alignment with MQS and applicable regulatory requirements.
Provide leadership and subject matter expertise in Quality Systems and Regulatory Compliance, ensuring effective implementation and sustainability.
Partner with cross‑functional teams to assess impacts, manage risks, and drive compliant and efficient solutions.
Support regulatory inspections, internal audits, and quality system assessments, including preparation, execution, and follow‑up activities.
Drive CAPA effectiveness, root cause analysis, and the use of structured problem‑solving methodologies.
Promote a culture of quality, accountability, and continuous improvement consistent with Medtronic values.

Minimum Qualifications:
Minimum of five (5) years of relevant experience leading and managing Quality System processes, projects, and initiatives.
Bachelor’s degree in Engineering, Science, or a related discipline.
Advanced technical or professional expertise in a Quality or Regulatory discipline, with demonstrated understanding of cross‑functional and organizational impact.
Advanced proficiency in English; bilingual capability is required.

Preferred Qualifications:
Certifications and/or formal training in Quality Systems and Medical Device regulations.
Certified Lead Auditor or Quality Auditor.
Lean Six Sigma Green Belt or Black Belt certification.
Training and demonstrated experience in CAPA, root cause analysis, and problem‑solving tools and techniques.

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

• 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.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

DIFFERENTIATING FACTORS

Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.

Organizational Impact: Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for a department, function or geography. Strive for continuous improvement and consistency in deliverables.

Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.

Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties . May interact on issues that have externally shared objectives.

Leadership and Talent Management: Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments. Authorizes hiring, firing, promotion and reward within own area.

Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

 

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. 

 

 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here