Medtronic
Application Window
We anticipate the application window for this opening will close on 17 Dec 2025.
About the Role As a Sr. Quality Systems Manager, you will play a pivotal role in ensuring product excellence and patient safety. The role is based in Colorado and leads critical quality initiatives including complaint investigations, trend analysis, product hold, filed corrective actions, and continuous improvement projects. This position offers the opportunity to make a meaningful impact on healthcare outcomes while working in a collaborative, innovation‑driven environment that values quality excellence and regulatory compliance.
Responsibilities
Lead compl…
Minimum Requirements
Bachelor’s degree required
Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.
Nice to Have
Proven experience in complaint investigation and management (CAPA systems)
Hands‑on experience with risk management tools (FMEA, FTA, PHA, ISO 14971)
Knowledge of medical device regulations: FDA 21 CFR Part 820, ISO 13485, MDR/IVDR
Experience leading internal and external audits (FDA, ISO, Notified Body)
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
Experience with quality management software and complaint handling systems (e.g., TrackWise, GCH)
Strong analytical and problem‑solving skills with data‑driven approach
Excellent communication skills in English (both written and verbal); additional languages are an advantage
Experience in multi‑site or global quality operations.
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 is at the core of our values. We recognize their contributions and share in the success they help to create. The following benefits and additional compensation are available to 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)
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, and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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. Compensation and benefits information pertains solely to candidates hired within the United States. Further details are available at the Medtronic benefits and compensation website.
About Medtronic Medtronic leads global healthcare technology and boldly attacks 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.
Equal Employment Opportunity 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.
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About the Role As a Sr. Quality Systems Manager, you will play a pivotal role in ensuring product excellence and patient safety. The role is based in Colorado and leads critical quality initiatives including complaint investigations, trend analysis, product hold, filed corrective actions, and continuous improvement projects. This position offers the opportunity to make a meaningful impact on healthcare outcomes while working in a collaborative, innovation‑driven environment that values quality excellence and regulatory compliance.
Responsibilities
Lead compl…
Minimum Requirements
Bachelor’s degree required
Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.
Nice to Have
Proven experience in complaint investigation and management (CAPA systems)
Hands‑on experience with risk management tools (FMEA, FTA, PHA, ISO 14971)
Knowledge of medical device regulations: FDA 21 CFR Part 820, ISO 13485, MDR/IVDR
Experience leading internal and external audits (FDA, ISO, Notified Body)
ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
Experience with quality management software and complaint handling systems (e.g., TrackWise, GCH)
Strong analytical and problem‑solving skills with data‑driven approach
Excellent communication skills in English (both written and verbal); additional languages are an advantage
Experience in multi‑site or global quality operations.
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 is at the core of our values. We recognize their contributions and share in the success they help to create. The following benefits and additional compensation are available to 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)
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, and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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. Compensation and benefits information pertains solely to candidates hired within the United States. Further details are available at the Medtronic benefits and compensation website.
About Medtronic Medtronic leads global healthcare technology and boldly attacks 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.
Equal Employment Opportunity 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.
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