Sr Clinical Quality Specialist

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

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

The Clinical Quality function partners with clinical study teams to ensure compliance with global regulatory requirements, Good Clinical Practice (GCP), and Medtronic quality standards across medical device clinical investigations and evaluations. The team supports audit execution, inspection readiness, quality oversight, vendor compliance, and corrective and preventive action management to help ensure the integrity and reliability of clinical data used for regulatory submissions.

This is a remote position supporting global clinical quality activities. The role requires 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 located within reasonable proximity to a major airport, preferably an international airport.

The Sr Clinical Quality Specialist plans and executes clinical quality assurance activities supporting medical device clinical studies. This 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. The position also supports inspection readiness activities, quality investigations, and corrective and preventive action programs to strengthen compliance across clinical operations.

Responsibilities may include the following and other duties may be assigned.

• 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.

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.

Preferred Qualifications

• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).