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Senior Principal Clinical Quality Specialist - Cardiac Surgery

Medtronic
USA-MN, United States, United Statesfull_timeVerifiedPosted 3 Jun 2025
💰 $234,000/yr

About the role

We anticipate the application window for this opening will close on - 10 Jun 2025


 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Careers That Change Lives 

In this exciting role as the Senior Principal Clinical Quality Specialist in the Cardiac Surgery Operating Unit, you will be responsible for providing experienced, comprehensive, and advanced expertise as the Operating Unit Quality Specialist. The Senior Principal Clinical Quality Specialist plays a critical role in ensuring the integrity, accuracy, and compliance of scientific data submitted to regulatory authorities. This position leads and conducts comprehensive audits, investigations, and quality reviews to assess adherence to regulatory requirements and internal standards. The specialist documents findings, recommends and tracks corrective and preventive actions, and may oversee clinical quality assurance databases and reporting. With expertise in GCP and regulatory protocols, this role may also advise on clinical documentation, support risk management activities, and contribute to regulatory submissions. Proficiency in Six Sigma methodologies and the ability to deliver training on current regulations further enhance the impact of this role in driving continuous quality improvement across clinical operations. Work will generally be self-directed but will be reviewed by the Manager at key time points. 

Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There are approximately 1.8 million cardiac surgical procedures in the world on an annual basis. Cardiac surgery remains extremely important in treating complex disease and remains the gold standard on which many of the other therapies being developed in Cardiovascular are based upon 

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here 

Primary location is Mounds View, MN 

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

 Travel up to 10%. 

A Day in the Life 

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

  • Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application. 

  • Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures. 

  • Documents audit observations and makes recommendations for corrective and preventive action. 

  • May

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Company

Medtronic

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