Quality Engineer II – CST – Lafayette, CO; Onsite
Listed on 2026-08-31
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous.
Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.
Journée type As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most.
Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe.
This position is not eligible for immigration sponsorship. Applicants must be authorized to work in the country of employment without sponsorship.
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. 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.
- 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.
Location:
Lafayette, CO (Onsite). This role will require
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