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Clinical Quality Manager

Medtronic

Lafayette Colorado United States of AmericaMidH-1B sponsor company
Sign in to applyVerified 2h ago
Location
Lafayette Colorado United States of America
Work model
On-Site
Level
Mid
H-1B history
106 approvals (FY2023)
Posted
1d ago

About this role

We anticipate the application window for this opening will close on - 18 Aug 2026   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. A Day in the Life 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

Clinical Quality Manager at Medtronic, Lafayette Colorado United States of America | Yoinka