Clinical Quality Manager

Clinical Quality Manager

Are you a people leader who thrives at the intersection of quality, compliance, and patient impact? Medtronic is seeking a Clinical Quality Manager to 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 may include the following and other duties may be assigned.

• 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.
• Documents 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.
• May create and maintain clinical quality assurance databases, reports, and files.
• Performs quality reviews and tracks corrective and preventive actions until closure.
• May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.
• May also audit operating systems, processes and procedures.
• May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.
• May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.
• May use six-sigma methodology.
• May provide training on GCP and current regulations for those undertaking clinical studies.

Must Have:
Minimum Requirements

• Bachelor's degree required

• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

Nice to Have

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

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.

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…