Sr Clinical Quality Specialist

Overview

Plan and execute clinical quality assurance activities supporting medical device clinical studies, including independent audits and inspection readiness.

What you'll do

• Plan, conduct, and document audits of clinical studies, Medtronic internally, investigational sites, hospitals, and third-party vendors.
• Assess compliance with regulatory requirements, Good Clinical Practice (GCP), and company quality standards.
• Evaluate the accuracy, completeness, and quality of clinical study data supporting medical device regulatory submissions.
• Conduct quality and compliance investigations and recommend corrective and preventive actions (CAPA).
• Track audit observations and CAPA activities through implementation and closure.
• Audit clinical systems, operational processes, and procedures to identify compliance risks and improvement opportunities.
• Support regulatory inspections, inspection readiness activities, and responses to audit or inspection findings.
• Maintain audit documentation, quality records, metrics, and reports in accordance with quality system requirements.

What you'll need

• Bachelor's degree with 4+ years of experience OR Advanced degree with 2+ years of experience in clinical quality, clinical research, auditing, or regulatory compliance.

Nice to have

• Experience independently conducting audits of clinical studies within a regulated healthcare industry.
• Experience auditing clinical sites, hospitals, contract research organizations (CROs), and/or third-party vendors.
• Experience with Good Clinical Practice (GCP), clinical study regulations, and quality systems.
• Ability to travel up to 60% domestically and internationally and work remotely from a location with access to a major airport.
• Experience supporting medical device clinical studies.
• Experience within the medical device, pharmaceutical, biotechnology, or consulting industry supporting MedTech clients in a clinical quality, auditing, compliance, or clinical research capacity.
• Experience supporting regulatory authority inspections and inspection readiness activities.
• Certification in quality auditing, clinical research, or quality management systems.
• Experience managing quality investigations and corrective and preventive action (CAPA) programs.

Details

• Remote position supporting global clinical quality activities.
• Travel of up to 60%, including domestic and international travel, is required.
• Candidates should be located within reasonable proximity to a major airport, preferably an international airport.
• Eligible for the Medtronic Incentive Plan (MIP) short-term incentive.