Sr Quality Systems Manager

Medtronic • Lafayette, CO

9d

About The Position

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. A Day in the Life As a Sr. Quality Systems Manager, where you'll play a pivotal role in ensuring product excellence and patient safety. Based in 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.

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 Haves

• 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.

Responsibilities

• 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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
• 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 (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees