Quality Systems Manager - Brooklyn Center, MN
Medtronic
Brooklyn Center, Minnesota, United States of America
Full-Time
$120,000
OfficeManager
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.
The Quality Systems Manager position provides leadership and resources to ensure compliance with all elements of the Quality Management System throughout the organization. This role also ensures quality system performance is measured and routinely reported or escalated to executive management. The position leads by example in the use of MPS (Medtronic Performance System) to drive continuous improvement and talent development, while facilitating “One Best Way” and the “Medtronic Mindset” within the Manufacturing Quality process. Reporting to the MECC Quality Site Leader, you will lead the QMS, CAPA, internal and external audits, change control and training.
Key Responsibilities as the Quality Systems Manager are:
Leadership & Quality Culture: Lead the manufacturing site toward excellence in product quality and operational excellence, fostering a culture that prioritizes quality and puts patients first. Champion continuous improvement and quality excellence, embedding quality in every aspect of operations.
Talent Development: Develop and implement comprehensive training programs to enhance team skills and capabilities. Mentor and coach employees, providing opportunities for professional growth and career advancement.
Inspection Readiness: Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices. Implement robust quality control processes and regular inspections to ensure compliance with regulatory requirements.
Strategic Partnership: Collaborate cross-functionally with colleagues in Global Operations & Supply Chain, Strategy & Technology, Supplier Quality, Micro & Sterilization Assurance, Regulatory Affairs, R&D, and others to drive Quality and Enterprise Operations strategies.
Quality Management: Oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards. Provide expertise in interpreting policies and regulations to ensure compliance.
Audit Leadership: Lead audit and inspection preparation, resolve findings, and liaising with auditing groups and inspectors. Facilitate uniform standards worldwide and enable best-practice sharing.
Continuous Improvement: Create a culture of continuous learning across areas of responsibility, identifying root causes of quality issues and institutionalizing organizational learning.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.
Bachelor’s degree required.
Minimum of 5 years of relevant Manufacturing Quality experience within a highly regulated industry OR an advanced degree with a minimum of 3 years of relevant Manufacturing Quality experience within a highly regulated industry.
This role is 100% onsite at our MECC - Brooklyn Center manufacturing site.
Nice to Have
Experience in Medical, Pharmaceutical or highly regulated product industry.
Experience managing a team of Quality Engineers and Specialists.
DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.
Demonstrated experience leading Kaizen Events and multiple Quality-related functions.
Experience with vascular / neurovascular products.
Strong leadership, change management, and transformation skills.
Excellent communication, interpersonal, and talent management skills.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
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 insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition 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 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), 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
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 95,000+ 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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findherea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.