Medtronic
Senior Quality Systems Manager, Design Quality Center of Expertise
Medtronic, Mounds View, Minnesota, United States
Overview
We anticipate the application window for this opening will close on 6 Oct 2025. 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. Role Summary
A Day in the Life
The Senior Quality Systems Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Design Control capabilities throughout the organization. In this role, you will proactively identify and implement large-scale initiatives that enhance rigor, productivity and user experience by leveraging cutting-edge technologies and innovative methodologies. This is an on-site position that requires candidates to work in the Mounds View, MN, Lafayette, CO, Boston, MA, Memphis, TN, or Santa Rosa, CA office 4-days per week minimum. Responsibilities
Lead enterprise-wide initiatives with emphasis on Design, Reliability & Manufacturability (DRM) to ensure product quality, regulatory compliance and operational excellence across all Medtronic Operating Units (OU). Apply your technical expertise to Put Patients First every day. Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer. Guide cross-functional teams through the Product Development Process (PDP) with a strong focus on positive design control outcomes and regulatory adherence. Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into early design phases. Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization. Leverage biomedical engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards. Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing expert guidance on compliance throughout the development lifecycle. Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and strengthen decision-making and solution design. Must Have: Minimum Requirements
Bachelor’s Degree with 7+ years of work experience in Quality, with 5+ years of managerial experience OR Advanced Degree with 5+ years of work experience in Quality with 5+ years of managerial experience Nice to Have: Preferred Qualifications
Experience leading complex projects/programs Experience with SPC, CAPA, NCMR, PDP processes Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously Ability to establish and maintain a trusted role with stakeholders across multiple functions PMP Certification Working knowledge of Quality System Regulations such as QSR 21 CFR 820, and ISO 13485:2016 Manufacturing Experience Green Belt Six Sigma/DRM Training/Certification Effective verbal and written communication, analytical, influencing and interpersonal skills Demonstrated working knowledge of process validation, statistical methods, risk management 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, interact with a computer, and communicate with peers and co-workers. Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. We recognize contributions and 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. locations (USD): $149,600.00 - $224,400.00. 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 certain locations in California. The offered rate complies with federal and local regulations and may vary based on experience, certification/education, market conditions, and location. Benefits for regular employees include Health, Dental and Vision insurance; Health Savings Account; Healthcare Flexible Spending Account; Life insurance; Long-term disability; Paid time off; 401(k) with employer match; Employee Stock Purchase Plan; and other programs. Some benefits may vary by location. About Medtronic
We lead global healthcare technology and tackle health problems 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. Learn more about our business and commitment to diversity. 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 law.
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We anticipate the application window for this opening will close on 6 Oct 2025. 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. Role Summary
A Day in the Life
The Senior Quality Systems Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Design Control capabilities throughout the organization. In this role, you will proactively identify and implement large-scale initiatives that enhance rigor, productivity and user experience by leveraging cutting-edge technologies and innovative methodologies. This is an on-site position that requires candidates to work in the Mounds View, MN, Lafayette, CO, Boston, MA, Memphis, TN, or Santa Rosa, CA office 4-days per week minimum. Responsibilities
Lead enterprise-wide initiatives with emphasis on Design, Reliability & Manufacturability (DRM) to ensure product quality, regulatory compliance and operational excellence across all Medtronic Operating Units (OU). Apply your technical expertise to Put Patients First every day. Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer. Guide cross-functional teams through the Product Development Process (PDP) with a strong focus on positive design control outcomes and regulatory adherence. Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into early design phases. Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization. Leverage biomedical engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards. Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing expert guidance on compliance throughout the development lifecycle. Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and strengthen decision-making and solution design. Must Have: Minimum Requirements
Bachelor’s Degree with 7+ years of work experience in Quality, with 5+ years of managerial experience OR Advanced Degree with 5+ years of work experience in Quality with 5+ years of managerial experience Nice to Have: Preferred Qualifications
Experience leading complex projects/programs Experience with SPC, CAPA, NCMR, PDP processes Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously Ability to establish and maintain a trusted role with stakeholders across multiple functions PMP Certification Working knowledge of Quality System Regulations such as QSR 21 CFR 820, and ISO 13485:2016 Manufacturing Experience Green Belt Six Sigma/DRM Training/Certification Effective verbal and written communication, analytical, influencing and interpersonal skills Demonstrated working knowledge of process validation, statistical methods, risk management 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, interact with a computer, and communicate with peers and co-workers. Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. We recognize contributions and 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. locations (USD): $149,600.00 - $224,400.00. 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 certain locations in California. The offered rate complies with federal and local regulations and may vary based on experience, certification/education, market conditions, and location. Benefits for regular employees include Health, Dental and Vision insurance; Health Savings Account; Healthcare Flexible Spending Account; Life insurance; Long-term disability; Paid time off; 401(k) with employer match; Employee Stock Purchase Plan; and other programs. Some benefits may vary by location. About Medtronic
We lead global healthcare technology and tackle health problems 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. Learn more about our business and commitment to diversity. 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 law.
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