Quality Engineer II – CST – Lafayette, CO (Onsite)

About the role

A Day in the Life As a Quality Engineer II, you will provide quality engineering leadership supporting commercial evaluation programs and operational quality initiatives across the CST portfolio. This role partners closely with Operations, Technical Services, Project Coordinators, Marketing, Regulatory Affairs, and Quality Systems to ensure compliance with Medtronic Quality System requirements while enabling business objectives.

Responsibilities

• Serve as the Quality Engineering representative supporting commercial evaluation programs and operational quality initiatives across the Cranial & Spinal Technologies portfolio.
• Provide quality leadership by ensuring compliance with Medtronic Quality System requirements, regulatory expectations, and business objectives.
• Lead complex CAPA investigations, nonconformance investigations, audit responses, and continuous improvement initiatives using risk-based problem-solving and root cause analysis.
• Partner cross-functionally with Operations, Engineering, Technical Services, Marketing, Regulatory Affairs, and Quality Systems to implement sustainable quality solutions.
• Develop and maintain quality standards, procedures, documentation, and traceability systems that support inspection readiness and operational excellence.
• Collaborate with Engineering and Manufacturing to establish inspection methods, testing strategies, and quality standards that ensure product reliability and process effectiveness.
• Support quality oversight for commercial evaluation programs, capital equipment management, field servicing, preventative maintenance, and product traceability.
• Support internal and external regulatory inspections and audits while ensuring corrective actions meet reliability, quality, and compliance requirements.

Requirements

Minimum Requirement (Basic Qualifications): To be considered for this position, the following Basic Qualifications must be evident on your resume
Bachelor’s degree in Engineering or Technical discipline with minimum of 2 years of relevant experience, OR
Master’s degree in Engineering or Technical discipline with minimum of 0 years of relevant experience.

Qualifications

Nice To Have (Preferred Qualifications):
Experience with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR, and medical device quality systems.
Demonstrated experience leading CAPA investigations, root cause analysis, audit support, and continuous improvement initiatives.
Experience supporting commercial operations, field evaluation programs, capital equipment, or technical service quality within the medical device industry.
Knowledge of manufacturing quality, supplier quality, inspection methods, process validation, and product reliability.
Strong cross-functional collaboration, communication, and influencing skills, with the ability to drive quality decisions across diverse teams.

Skills

None specified in the job posting.

Benefits

Salary ranges for U.S (excl. PR) locations (USD):$79,200.00 - $118,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).