Manager Qualitätssysteme

We anticipate the application window for this opening will close on - 17 Oct 2025At 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.# A Day in the Life As a Quality Systems Manager, where you'll play a pivotal role in ensuring product excellence and patient safety. Based in Lafayette, Colorado you'll lead 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 may include the following and other duties may be assigned. Leads complaint investigation processes - Manages the end-to-end complaint handling system, conducts root cause analyses, determines product impact, and ensures timely closure of complaints in compliance with ISO 13485, FDA QSR, and MDR requirements Analyzes quality trends and implements corrective actions - Identifies patterns in complaints, non-conformances, and quality metrics; drives data-driven decision making and implements preventive actions to eliminate recurring issues. Drives quality and product improvement projects - Initiates and manages cross-functional improvement initiatives, implements Lean / Six Sigma methodologies, and ensures sustainable quality enhancements throughout the product lifecycle. Provides oversight for quality programs and systems - Develops and maintains quality management systems, processes, and procedures ensuring compliance with internal policies and external standards (ISO 13485, FDA 21 CFR Part 820, MDR / IVDR). Leads audit and inspection readiness - Prepares for and manages regulatory inspections (FDA, Notified Body, ISO), coordinates responses to audit findings, and serves as primary liaison with auditors and inspectors throughout all audit stages. Ensures regulatory compliance - Provides expertise in interpreting and implementing regulatory requirements, including medical device directives, FDA regulations, and international standards; ensures organizational adherence to all applicable guidelines. Prepares quality documentation and reports - Authors and reviews CAPAs (Corrective and Preventive Actions), investigation reports, quality metrics summaries, and regulatory submissions for internal and external stakeholders. Works with cross-functional teams - Collaborates with R&D, Operations, Regulatory Affairs, and Clinical teams to provide quality oversight, process analysis, and continuous improvement support. Coordinates legal and regulatory requests - Supports government investigations, regulatory inquiries, and litigation matters by providing accurate documentation and quality-related information Maintains and improves quality systems - Ensures QMS programs and policies are regularly reviewed, updated, and optimized to reflect current best practices and regulatory changes. Promotes global quality standards - Facilitates uniform quality standards across sites, enables best practice sharing, and fosters achievement of quality excellence globally. Must Have : Minimum Requirements Bachelor's degree required

• Minimum of 5 years of relevant experience, OR Master's degree with a minimum of 3 years of relevant 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 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) : $119,200.00 - $178,800.00This 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 : # 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 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

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