Quality Engineering Manager - Brooklyn Park

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. The Quality Engineering Manager at our Brooklyn Park, MN facility is responsible for driving quality performance, maintaining compliance with internal and external requirements, and providing day-to-day leadership for quality operations of perfusion systems manufacturing. Working closely with site leadership and cross-functional partners across multiple functions, this leader will help ensure products are manufactured in a state of control and meet Medtronic’s high standards for safety, quality, compliance, and reliability. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 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. Responsibilities may include the following and other duties may be assigned. Lead, manage, coach, and develop a team of Quality Engineers supporting manufacturing operations at the Brooklyn Park facility. Provide day-to-day oversight of quality engineering activities supporting perfusion systems manufacturing for Medtronic’s Cardio Vascular Surgery business. Ensure quality operations are conducted in compliance with Medtronic policies, internal procedures, quality system requirements, and applicable external regulatory requirements. Monitor, analyze, and drive improvement of site quality key performance indicators, including product quality, process quality, nonconforming product, CAPA, audit readiness, and other operational quality metrics. Partner with Operations, Manufacturing Engineering, Supplier Quality, Sterilization Assurance, and site leadership to identify, prioritize, and resolve quality and compliance issues. Develop, evaluate, implement, and maintain technical quality assurance and control systems, reliability systems, and standards pertaining to materials, techniques, manufacturing processes, and company products. Lead or support investigations, root cause analysis, corrective and preventive actions, and risk-based decision-making for quality issues impacting manufacturing operations. Provide quality oversight for process changes, validations, manufacturing controls, quality planning, and continuous improvement activities. Ensure effective documentation practices and maintenance of quality records throughout applicable product and process lifecycle phases. Establish operational plans and implement policies, strategies, and priorities for the Quality Engineering function. Organize and coordinate activities with internal partners, outside suppliers, and consultants, as needed, to ensure timely delivery of quality-related commitments. Communicate with internal and external customers, suppliers, and vendors regarding ongoing quality operations, quality performance, and issue resolution. Drive continuous improvement and consistency in quality deliverables, processes, and team performance. Support audit and inspection readiness activities, including preparation, execution, response, and remediation. Escalate quality risks, compliance concerns, and product performance issues appropriately to site and business leadership. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor’s Degree in Engineering or scientific related field with 5+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 3+ years of work experience in Quality and/or experience in a regulated industry Nice to Have Working knowledge of FDA Quality System Regulation, ISO 13485, and applicable global regulatory requirements Experience with nonconforming material processes, CAPA systems, deviation management, and root cause investigations Demonstrated use of quality metrics and KPIs to drive operational performance and compliance improvements Lean, Six Sigma, or similar continuous improvement experience 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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected] . ‌ 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):$142,400.00 - $213,600.00 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). 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 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 find here a 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.