Senior Remote Clinical Quality Auditor - MedTech

Medtronic plc; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Medtronic plc is seeking a Sr Clinical Quality Specialist to lead audits of clinical studies, sites, and vendors globally. You will ensure adherence to GCP and company quality standards, participate in inspection readiness, and drive CAPA programs to strengthen regulatory compliance across clinical operations.

The role is remote with up to 60% travel domestically and internationally. A Bachelor's degree + 4+ years (or advanced degree + 2+ years) in clinical quality or related fields is required.

Qualifications

• 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.

Responsibilities

• Plan, conduct, and document audits of clinical studies, investigational sites, hospitals, and third-party vendors.
• Assess regulatory compliance with GCP and company quality standards.
• Evaluate accuracy and quality of clinical study data for regulatory submissions.
• Conduct quality and compliance investigations and recommend CAPA actions.
• Track audit observations and CAPA activities through implementation and closure.
• Maintain audit documentation, quality records, metrics, and reports per quality system requirements.

Skills

Auditing

Regulatory compliance

GCP knowledge

Quality systems

CAPA

Education

Bachelor's degree + 4+ years

Advanced degree + 2+ years

Tools

Quality auditing tools

Job description

Medtronic plc is seeking a Sr Clinical Quality Specialist to lead audits of clinical studies, sites, and vendors globally. You will ensure adherence to GCP and company quality standards, participate in inspection readiness, and drive CAPA programs to strengthen regulatory compliance across clinical operations.

The role is remote with up to 60% travel domestically and internationally. A Bachelor's degree + 4+ years (or advanced degree + 2+ years) in clinical quality or related fields is required.