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

Medtronic•Lafayette, CO

2d•$98,400 - $147,600•Onsite

About The Position

As a Senior Quality Engineer, 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. You will serve as a key quality representative responsible for CAPA investigations, audit readiness, process improvements, quality system compliance, and operational oversight of commercial evaluation programs, capital equipment management, servicing and preventative maintenance activities, and field evaluation processes. Your work will directly contribute to maintaining product quality, regulatory compliance, and operational excellence while supporting innovative technologies that improve patient care.

Requirements

Bachelor’s degree in Engineering or Technical discipline with minimum of 4 years of relevant experience, OR
Master’s degree in Engineering or Technical discipline with minimum of 2 years of relevant experience, OR
PhD in Engineering or Technical discipline with minimum of 0 years of relevant experience.
Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

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.
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

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.