We anticipate the application window for this opening will close on - 6 Dec 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

In this exciting role as a Quality System Manager - Change Control, you will have responsibility for leading the QMS change control process for the Medtronic Diabetes business.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

This position is expected to be onsite, with the possibility to be at a hybrid capacity position which requires 3 days in the office and 2 days working in a remote capacity.

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.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads the QMS change control process, including QMS document changes and product related changes in the QMS software.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• 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.

Required Knowledge and Experience: 

• Requires a Baccalaureate degree
• Minimum of 5 years relevant experience in Quality Management setting in a regulated industry, or advanced degree with a minimum of 3 years prior relevant experience.

Nice to Have:

• 10+ years of work experience in Quality Management setting in a regulated industry
• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
• Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
• Capable of effectively managing multiple demands from a variety of sources.
• Strong expertise with managing complex situations, comfortable escalating issues and operating in grey area.
• Excellent written and verbal communication abilities
• Working knowledge in the medical device industry, including working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
• Experience supporting continuous improvement projects
• Strong critical thinking and analytical skills

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 requi