Clinical Quality Manager

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

About the role

A people leader who thrives at the intersection of quality, compliance, and patient impact, you will lead and elevate clinical quality systems, compliance, and operational excellence across the Surgical organization. This role offers a unique opportunity to lead a team that plays a critical role in protecting patients, ensuring the integrity of clinical research activities, strengthening stakeholder trust, and driving quality excellence in a highly regulated environment.

In this leadership role, you will develop and empower a high-performing team through clear prioritization, coaching, and readiness for audits, inspections, and quality-related assessments. You will proactively identify, assess, and escalate quality and compliance risks in a timely, decision-ready manner while ensuring adherence to applicable regulations, standards, and internal processes supporting clinical research and clinical operations. Working closely with stakeholders across the Clinical, Medical Affairs & HEPR (CMAH) organization and key cross-functional partners, you will help drive alignment, foster a culture of quality, and continuously improve processes and standards to increase efficiency, consistency, compliance, and inspection readiness.

If you are energized by leading through complexity, building strong partnerships, fostering a culture of quality, and developing teams that deliver with confidence, integrity, and a patient-first mindset, this role offers meaningful scope, visibility, and impact.

Responsibilities

• Lead and develop a high-performing team through clear prioritization, coaching, and capability building to deliver quality outcomes at scale.
• Assess accuracy and quality of data submitted to outside the CMAH team including regulatory agencies.
• Lead audit readiness by conducting and performing investigations and ensure conformance to regulations and company standard operating procedures.
• Document audit observations and make recommendations for corrective and preventive action.
• Drive QMS/QDR (e.g., CQFR/QMR) forums and reporting by consolidating quality data, preparing review materials, and facilitating leadership discussions to inform decisions and actions.
• Proactively identify and manage risks and issues by assessing trends, surfacing gaps, and escalating concerns in a clear, decision-ready manner.
• Own and improve clinical quality processes and standards by identifying opportunities to increase efficiency, consistency, and inspection readiness.
• Partner cross-functionally with clinical, regulatory, and quality teams to resolve findings, address deficiencies, and ensure alignment on expectations.
• Create and maintain clinical quality assurance databases, reports, and files.
• Perform quality reviews and track corrective and preventive actions until closure.
• Act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.
• Audit operating systems, processes, and procedures.
• Support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.
• Plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.
• Use six-sigma methodology.
• Provide training on GCP and current regulations for those undertaking clinical studies.

Requirements

• Bachelor’s degree required.
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Skills

• Knowledge of Medtronic systems.
• Understanding of the clinical Quality and Regulatory environments.
• Experience in the Medical Device Industry.

Benefits

Medtronic offers a competitive salary and flexible benefits package. The following benefits and additional compensation are available to regular employees who work 20+ hours per week:

• Health, Dental, and Vision insurance.
• Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans, including the Medtronic Incentive Plan (MIP).
• 401(k) plan plus employer contribution and match.
• Short-term disability.
• Paid time off and 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).

Note: Some benefits may not apply to workers in Puerto Rico. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Pay

Salary ranges for U.S. (excluding Puerto Rico) locations: $131,200.00 - $196,800.00 (USD). The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Schedule

The physical demands described 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: The employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers.