Quality Engineer II, CST: Elevate Spine & Cranial Tech | Onsite

Medtronic plc; Lafayette, Northern (CO, KY); Hybrid; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health, Dental & Vision

HSA

FSA

Life Insurance

Long-term Disability

Tuition Assistance

Well-being Program

401(k) with Match

Paid Time Off

Paid Holidays

Employee Stock Purchase Plan

Employee Assistance Program

Retirement Plan Upgrade

Capital Accumulation Plan

Job summary

Medtronic plc in Lafayette, CO is seeking a Quality Engineer II to lead quality initiatives across the Cranial & Spinal Technologies portfolio. The role partners with Operations, Engineering, Regulatory, and Marketing to ensure compliance and drive improvements in CAPA, audits, and product reliability.

The position emphasizes collaboration, risk-based problem solving, and supporting innovative medical technologies that enhance patient care.

Qualifications

• Bachelor's degree in Engineering or a technical field with 2+ years of relevant experience, or a Master's degree with 0+ years of experience.
• Experience leading CAPA investigations and root cause analyses.
• Familiarity with quality systems, regulatory expectations, and continuous improvement.

Responsibilities

• Serve as Quality Engineering representative supporting commercial evaluation programs and operational quality initiatives across CST portfolio.
• Provide quality leadership ensuring compliance with Quality System requirements, regulatory expectations, and business objectives.
• Lead CAPA investigations, nonconformance investigations, audit responses, and continuous improvement using root cause analysis.
• Collaborate with Operations, Engineering, Marketing, Regulatory Affairs, and Quality Systems to implement sustainable quality solutions.
• Develop and maintain quality standards, procedures, and traceability systems for inspection readiness and excellence.
• Collaborate with Engineering and Manufacturing to establish inspection methods and testing strategies.
• Support internal and external regulatory inspections and audits and ensure corrective actions meet reliability and compliance.

Skills

CAPA investigations leadership

Root cause analysis

Quality systems

Cross-functional collaboration

Audits & inspections

Education

Bachelor's degree in Engineering or Technical discipline

Master's degree in Engineering or Technical discipline

Tools

QMS software

Job description

Medtronic plc in Lafayette, CO is seeking a Quality Engineer II to lead quality initiatives across the Cranial & Spinal Technologies portfolio. The role partners with Operations, Engineering, Regulatory, and Marketing to ensure compliance and drive improvements in CAPA, audits, and product reliability.

The position emphasizes collaboration, risk-based problem solving, and supporting innovative medical technologies that enhance patient care.