Senior Quality Engineer, Process Validation & Compliance

Medtronic plc; Montana; On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic is seeking a Senior Quality Engineer based at the West Valley, Utah manufacturing facility to lead process validation and quality system execution in a tightly regulated medical device environment.

The role partners with engineering and manufacturing teams to ensure compliant, effective processes, drive CAPA and NCMR activities, and sustain product quality. Strong CFR knowledge and Minitab proficiency are expected.

Qualifications

• Bachelor's degree in Engineering, Science, or technical field required.
• Experience with process validation in regulated environments preferred.
• Experience with FDA-regulated medical device manufacturing is a plus.
• Knowledge of CFR requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
• ASQ CQE, Lean Six Sigma certification, or similar quality certification is desirable.
• 2+ years of experience executing process validation activities across the full validation lifecycle.

Responsibilities

• Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
• Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
• Drive root cause investigations, CAPA, and NCMR activities to resolve quality issues and prevent recurrence.
• Analyze quality and process performance data using statistical methods to support risk-based decision making.
• Develop and implement inspection, testing, and evaluation methods to verify product quality and process capability.
• Support qualification and validation of manufacturing equipment, processes, and test methods.
• Ensure quality documentation and validation records comply with regulatory and quality system requirements.
• Mentor quality and engineering colleagues on complex quality and validation projects.

Skills

4+ years experience

Process validation

Minitab

Regulatory/compliance

Quality systems

Education

Bachelor's degree in Engineering/Science/technical field

Master's degree in Engineering/Science/technical field

PhD

Tools

Minitab

Job description

Medtronic is seeking a Senior Quality Engineer based at the West Valley, Utah manufacturing facility to lead process validation and quality system execution in a tightly regulated medical device environment.

The role partners with engineering and manufacturing teams to ensure compliant, effective processes, drive CAPA and NCMR activities, and sustain product quality. Strong CFR knowledge and Minitab proficiency are expected.