Sr Clinical Quality Specialist

Medtronic plc; Mumbai; Remote; INR 1,800,000 - 2,400,000; Full time

Job summary

Medtronic plc in Mumbai, India is seeking a Sr Clinical Quality Specialist to lead audits of clinical studies, investigate quality issues, and ensure adherence to GCP and company procedures across global medical device programs. This remote role requires collaboration with internal teams, sites, CROs, and vendors.

Travel up to 60% is expected, including international trips. You will maintain audit documentation, support inspections, CAPA management, and drive continuous quality improvement

Qualifications

• Bachelor's degree with 4+ years of experience OR Advanced degree with 2+ years in clinical quality, clinical research, auditing, or regulatory compliance.
• Experience with Good Clinical Practice (GCP) and regulatory compliance.
• Ability to travel up to 60% domestically and internationally.
• Experience auditing clinical sites, hospitals, CROs, or third-party vendors.

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 regulatory submissions.
• Conduct quality and compliance investigations and recommend CAPA actions.
• Track audit observations and CAPA activities through implementation and closure.
• Audit clinical systems, processes, and procedures to identify risks and improvement opportunities.
• Support regulatory inspections and responses to audit or inspection findings.
• Maintain audit documentation and quality records per quality system requirements.

Skills

Auditing

Regulatory compliance

GCP knowledge

Travel willingness

Education

Bachelor's or advanced degree in clinical quality/related field

Job description

Remote

Mumbai, Maharashtra, India

Full time

R79472

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).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .