We anticipate the application window for this opening will close on - 20 Jan 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

Senior Quality Systems Specialist

Careers that Change Lives

We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

In this exciting role as a Senior Quality Systems Specialist, you will play a pivotal part in maintaining and enhancing our quality management systems to ensure compliance with industry standards and regulations. You will collaborate with cross-functional teams to implement quality initiatives, support process improvements, and ensure product excellence throughout the organization. In this position you will provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Your responsibilities will include managing process changes, potentially acting as a Change Analyst, participating in QMS-related CAPAs, and facilitating manufacturing training programs, among other tasks. This multifaceted role requires a proactive approach to process improvement and the ability to collaborate effectively across departments.

The Mechanical Circulatory Support Operating Unit is responsible for Medtronic’s heart pump program. Called the HeartWare™ HVAD™ System, this business provides a left ventricular assist device (LVAD) that helps patients’ hearts pump and increases the amount of blood that circulates through their bodies. The HVAD System features the world's smallest, commercially available, centrifugal flow pump. 

This position will be a hybrid position to be in Mounds View, MN or Miami Lakes, FL (preferred) within the MCS OU.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life 

In general, the following responsibilities apply for the Senior Quality Systems Specialist role. This includes, but is not limited to the following:

• Provide guidance and manage QMS document maintenance for Quality Systems documents
• 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.
• Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs.
• Facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations and regulatory.

Qualifications  

Must Have: Minimum Requirements 

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME 

• Bachelor's degree in a related field such as Quality Management, Engineering, or Life Sciences with a minimum of 4 years of experience or advanced degree with a minimum of 2 years experience.

Nice to Have 

• Experience in Class III active implantable medical device.
• Experience in MAP Agile and/or Windchill PLM software
• Experience in a quality assurance or quality systems role, preferably within the medical device or pharmaceutical industry.
• Knowledge of quality management systems, including ISO 13485, FDA regulations, and other relevant standards.
• Excellent analytical, problem-solving, and organizational skills.
• Strong communication and interpersonal skills, with the ability to work collaboratively across teams.
• Proficient in using quality management software and tools.