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Jobs · Quality Assurance · Colorado

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

Medtronic · Lafayette, CO · 1 mo ago
On-siteQuality Assurance$98k–$148k/yrFull-time

About the role

This position is not eligible for immigration sponsorship. Applicants must be authorized to work in the country of employment without sponsorship.

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

  • 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.

Nice to have

  • 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.

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 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.

Skills

  • 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.

Benefits

For U.S. (excluding Puerto Rico) locations, the offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).

The following benefits and additional compensation are available to all regular employees: 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).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic Benefits And Compensation Plans.

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