Quality System Specialist

Medtronic • Lafayette, CO

3d • $75,200 - $112,800 • Onsite

About The Position

Our Cranial & Spinal Technologies (CST) operating unit advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide.

In this dynamic role as a Quality Systems Specialist, you will play a key role in supporting 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's degree with a minimum of 2 years of quality assurance experience in the medical device or pharmaceutical industry, OR a Master's degree with 0 prior experience required.
• 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.
• 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.
• Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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 supporting 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.

Responsibilities

• Support 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.
• Contribute to audit and inspection readiness, support 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.
• Support 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

• Competitive Salary
• flexible Benefits Package
• 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: Principal