We anticipate the application window for this opening will close on - 27 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 on a mission to alleviate pain, restore health, and extend life. As a Senior Quality Systems Specialist, you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters.

 

As a Senior Quality Systems Specialist, you will:

 

·       Lead and support Quality System processes, such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control.

·       Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other global regulations.

·       Facilitate and support internal and external audits (e.g., FDA, Notified Body, ISO) including audit readiness activities, evidence preparation, and post-audit follow-ups.

·       Partner cross-functionally to evaluate, improve, and harmonize quality system processes and procedures.

·       Analyze and interpret quality system data to identify trends and recommend opportunities for improvement.

·       Support and mentor junior team members in the interpretation and application of quality system requirements.

·       Participate in global projects and initiatives, helping to drive standardization and best practices across sites.

 

Must Have: Minimum Qualifications

 

·       Bachelor’s Degree and 4 years of relevant experience OR

·       Advanced Degree and 2 years of relevant experience

Nice to Have: Preferred Qualifications

 

·       In-depth knowledge of FDA QSR, ISO 13485, and EU MDR.

·       Strong problem-solving, critical thinking, and analytical skills.

·       Excellent written and verbal communication skills.

·       Experience working in a cross-functional, matrixed environment.

·       ASQ certification (e.g., CQA, CQE, or CMQ/OE).

·       Experience with Audit Management Systems (e.g., TrackWise, ETQ).

·       Understanding of risk management (ISO 14971), software validation, or design control processes.

·       Prior experience supporting multiple site operations or global quality systems.

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