Enterprise FCA Planning (Sr. Quality Sys. Mgr.) at Medtronic in Minneapolis, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 6 Dec 2024

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
Strategize, coordinate and execute FCA plan through strong collaboration with operating unit and regions. Responsible for enterprise FCA planning process. Oversee team of associates to manage FCA process and execute per quality system requirements and procedures.
Responsibilities may include the following and other duties may be assigned.

• Prioritizes patient safety and regulatory compliance by acting swiftly in collaboration with cross functional partners to ensure timely FCA planning and approval.


• Partner with OU and region to drive alignment on FCA strategy and execute per plan by following released procedure steps


• Develop team, coach and mentor the direct staff to be high performing and engaged individuals. Actively develop team skillset, expertise and talent


• Follow the process per procedures, align with OUs as needed to ensure the standard process is followed and executed


• Manage team capacity and workload to ensure activities are executed in a timely manner and complete


• Supports continuous improvement projects to increase effectiveness, efficiency, and compliance.


• Ensures alignment with legal and ethical standards of the organization.

Differentiating Factors:

• Organizational Impact: Sets objectives for the enterprise planning team and provide leadership across all portfolio of FCA


• Innovation and Complexity: Continue to identify areas of opportunity to drive process improvement, and use technology to efficiently mature FCA planning process


• Communication and Influence: Communicates with OU leaders and regional partners, strategic thinker to drive outcomes through influence and strong communication

Required Knowledge and Experience:

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.


• Requires a Baccalaureate degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years relevant experience.

Must Have: Minimum Requirements

Include: To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor's degree and minimum of 2 years of relevant experience or advanced degree with minimum of 0 years of relevant experience.


• Capable of effectively managing multiple demands from a variety of sources.


• Strong expertise with managing complex situations, comfortable escalating issues and operate in grey area

• Excellent written and verbal communication abilities.


• Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.


• Experience supporting internal and external audits


• Experience supporting continuous improvement projects

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):$144,800.00 - $217,200.00

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.