Senior Quality Systems Specialist at Medtronic in Minneapolis, Minnesota

Job Description:

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 role, you will have responsibility for working with the Neuromodulation/Pelvic Health post market quality team to ensure compliance with issue investigation, field action, and product hold order requirements and documentation for initiation through closure. An ideal candidate would have a deep understanding of Medtronic's distribution methods, SAP, GSS, FactoryWorks, Excel, Agile, and MRCS.

Responsibilities may include but are not limited to:

• Provides oversight for developing and maintaining 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.


• Works directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet regulations.


• Prepares reports and necessary documentation (ex FCA customer confirmation, PHO closure status, FCA/PHO bounding reports) and provides to applicable stakeholders, both internal and external.


• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.


• Identifies manufacturing data as well as current product location information globally to support bounding and scoping for issue investigations, product hold orders, and field corrective actions


• Ownership of OU FCA execution follow-up activities to ensure timely notification of consignees and robust documentation

Required Knowledge and Experience:
Requires a Baccalaureate degree

Minimum of 4 years of quality systems experience, or advanced degree with a minimum of 2 years experience.

Nice to Have

• Medical device industry experience


• Understanding of supply chain and distribution


• Knowledge of systems including SAP, FactoryWorks, Agile, and Business Objects


• Experience with PHO/FCA execution

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 range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$86,400.00 - $129,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.