Sr Clinical Quality Specialist

Medtronic

18h•Remote

About The Position

The Sr Clinical Quality Specialist plans and executes clinical quality assurance activities supporting medical device clinical studies. The role independently conducts audits of clinical studies, investigational sites, hospitals, and third-party vendors to assess compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures. It also supports inspection readiness, quality investigations, and corrective and preventive action programs to strengthen compliance across clinical operations. This is a remote position supporting global clinical quality activities. The role involves frequent collaboration with internal stakeholders, healthcare professionals, clinical sites, hospitals, contract research organizations, third-party vendors, and external partners. Travel of up to 60%, including domestic and international travel, is required. Candidates should be within reasonable proximity to a major airport, preferably an international airport.

Requirements

Bachelor's degree with 4 or more years of experience, or an advanced degree with 2 or more years of experience in clinical quality, clinical research, auditing, or regulatory compliance.

Nice To Haves

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.

Responsibilities

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.