Senior Quality Systems Specialist

Medtronic • Lafayette, CO

5d • Onsite

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 Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In this dynamic role as a Senior Quality System Specialist, you will play a key role in overseeing the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of quality and performance.

Requirements

• Bachelor degree with minimum of 4 years quality assurance experience in medical device or pharmaceutical industry.

Nice To Haves

• Demonstrated continuous improvement mindset with hands-on experience using quality tools and process improvement methodologies.
• Strong working knowledge of Quality Management Systems (QMS) compliant with ISO 13485 standards, FDA regulatory, EU MDR, and MDSAP requirements.
• Proven experience managing Corrective and Preventive Actions (CAPA), audits, and Change Control Processes.
• Functional experience in root cause investigation, including application of root cause analysis tools, corrective/preventive action planning, execution, and verification of effectiveness.
• Proficiency with TrackWise and Agile PLM systems.
• Familiarity with change management frameworks and document control processes.
• Excellent communication (verbal and written), critical thinking, interpersonal, organizational, time management, and presentation skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and collaboratively within teams and across functions.
• 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.

Responsibilities

• Lead the Corrective and Preventive Actions (CAPA) Program, including root cause investigations, application of analysis tools, action planning, execution, and verification of effectiveness.
• Prepare and deliver communications, reports, and documentation related to CAPA activities to internal and external stakeholders.
• Drive audit and inspection readiness—manage all phases of audits, resolve findings, and serve as liaison with auditors, inspectors, and internal stakeholders.
• Apply a continuous improvement mindset to enhance quality tools, processes, and overall system effectiveness.
• Provide expert interpretation of policies, regulations, and standards to ensure full compliance across the organization.
• Coordinate responses to legal or regulatory requests, including those supporting investigations or litigation.
• Maintain and update quality assurance programs and policies to reflect evolving standards and best practices.
• Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office to effectively maintain the Quality Management System.
• Generates and analyzes standard reports (e.g., Periodic Review, External Standards, Training, and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP

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, 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 (subject to IRS earning minimums), and 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