Manager - FCA (Field Corrective Action) Closure at Medtronic in Mounds View, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 23 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
Responsible to coordinate with FCA Execution, Product Hold Order (PHO), Regions and Operating unit to close FCA with required notification to regulatory agency. Oversee and Manage the team to execute FCA closure activities. Support internal and external audit as needed. Drive strategic decision and improvements within the FCA processes.
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 closure and approval.


• Partner with Operating Unit (OU), Global Deliver Quality (GDQ), PHO and region to document and close FCA post execution of all activities


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


• Support internal & external audits as needed to represent the process and team


• Drive continuous improvement projects to improve effectiveness, efficiency, and compliance


• Ensures alignment with legal and ethical standards of the organization

Differentiating Factors:

• Organizational Impact: Coordinate and close FCAs timely by putting Patient First to address product quality issues in the field


• 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):$109,600.00 - $164,400.00

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).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

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.