Clinical Quality Manager

Medtronic•Mounds View, MN

2d•$131,200 - $196,800•Onsite

About The Position

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.

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.
U.S. work authorization is required for roles below Principal level.

Nice To Haves

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

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.
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.