We anticipate the application window for this opening will close on - 28 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

At Medtronic, we’re driven by our Mission to alleviate pain, restore health, and extend life. As a Principal Quality Systems Specialist, you’ll play a key role in ensuring the integrity of our quality systems, supporting regulatory compliance, and helping us deliver innovative medical technologies that transform lives.

 

In this role, you will provide leadership and subject matter expertise in the development, implementation, and continuous improvement of our Quality Systems. You will work cross-functionally to ensure compliance with internal policies and procedures as well as global regulatory requirements. This position offers the opportunity to influence and shape quality culture while supporting strategic and operational initiatives.

 

Key Responsibilities:

• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with Medtronic policies and global regulatory requirements.
• Interpret and apply regulatory, governmental, and internal policies to ensure adherence and guide others in compliance efforts.
• Partner with operational teams to assess processes, identify areas for improvement, and implement corrective actions to meet quality and regulatory standards.
• Lead preparation for audits and inspections, including strategy development, readiness activities, hosting, and follow-up, ensuring timely resolution of findings.
• Coordinate documentation and reporting activities such as Corrective and Preventive Actions (CAPAs), audit responses, and quality system metrics.
• Support legal and regulatory requests in response to government investigations or litigation as needed.
• Drive consistency and excellence by facilitating global standards and sharing best practices across sites and teams.
• Champion a culture of quality, continuous improvement, and proactive compliance across the organization.

 

Must Have: Minimum Requirements

• Bachelor’s degree with a minimum of 7 years of relevant experience OR Advanced degree with 5 years or relevant experience

 

Nice to Have: Preferred Qualifications

• Experience in a regulated industry (e.g., medical device, pharmaceutical, or life sciences).
• Demonstrated knowledge of global regulatory standards (e.g., FDA QSR, ISO 13485, MDR).
• Experience leading audits or inspections and working with regulatory bodies.
• Strong project management and cross-functional collaboration skills.
• Excellent verbal and written communication skills.
• Ability to influence without authority and drive alignment across teams.
• Experience working in a global matrix organization.

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. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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