We anticipate the application window for this opening will close on - 11 Sep 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 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.

The Sr. Quality System Specialist position is one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality systems support in development and maintenance of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitate the application of our Quality Management System in developing and sustaining our product portfolio.

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

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance (FDA & International Medical Device Directives / Regulations, ISO requirements, etc.). 
• Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program.
• Maintains and develops the ACM OU training program (Cornerstone On Demand CSOD) and process.
• Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Owns and drives investigations, Root Cause Analysis and resulting Corrective and Preventive Actions, and creates reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Maintains Key Performance metrics and performs trend analyses and reports compliance observations to identify areas in need of improvement.
• Applying statical methodology in tracking and trending Quality metrics and developing models/visual representation of the data.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Excellent writing and editing skills, and computer skills in the English language.
• Ability to travel within the US and Internationally on occasion.

Must Have: Minimum Requirements                 

• Bachelor’s degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience

 
Nice to Have

• Auditing Experience
• Learning Management System experience (Cornerstone on Demand) and training program management
• Statistical Analysis and Visualization tools (Power BI, etc.)

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