At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Join a diverse team of innovators who bring their worldview their unique backgrounds and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Careers That Change Lives

In this exciting role as the Senior Quality Systems Program Manager you will lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS) focusing on enhancing customer experience through innovative solutions. Additionally this role will lead other cross-functional programs and initiatives to achieve key business objectives.

Responsibilities may include the following and other duties may be assigned.

• Lead integration of new product lines into the Neuromodulation and Pelvic Health QMS ensuring alignment with business objectives and compliance requirements.

• Drive the development and implementation of the next-generation QMS toolset to improve user experience and engagement within the Quality System.

• Plan execute and manage process improvement initiatives using methodologies such as Lean and Six Sigma.

• Evaluate existing processes identify improvement opportunities and develop metrics to measure performance and success.

• 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.

• Lead audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

• 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 companys mission globally.

Location: Fridley MN

• This is ONSITE position in Fridley Minnesota.

Ability to travel up to:10%

Must Have (Minimum Requirements)

To be considered for this role please ensure the minimum requirements are evident on your resume.

• Bachelors degree required with a minimum of 7 years in Quality Systems within the medical device industry.

• OR advance degree with a minimum of 5 years of in Quality Systems within the medical device industry.

Nice to Have (Preferred Qualifications)

• Strong understanding of global regulatory requirements for medical devices includingFDA regulations (e.g. 21CFR Part 820)ISO 13485 Medical Device Directive and European Medical Device Regulation.

• Demonstrated experience leading projects and programs from ideation to implementation.

• Experience leading cross-functional project teams and managing complex programs with competing priorities.

• Expertise in Lean Six Sigma or other process improvement methodologies.

• Demonstrated ability to influence across functions and levels including senior leadership and external stakeholders.

• Strong communication and presentation skills with the ability to simplify complex information for diverse audiences.

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.