Senior Quality Engineer — Process Validation & CAPA

Medtronic plc; Salt Lake City (UT); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic plc in West Valley City, Utah, is seeking a Senior Quality Engineer for an onsite role with a Monday–Thursday schedule from 3:30 p.m. to 2:00 a.m.

The position emphasizes process validation, quality system execution, and collaboration with engineering and manufacturing teams to ensure compliant, high-quality manufacturing processes. You will lead validation activities, support CAPAs/NCMRs, analyze data with statistical methods, and contribute to regulatory compliance within a regulated

Qualifications

• Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience.
• Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience.
• PhD

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, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
• Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
• Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
• Support qualification and validation of manufacturing equipment, processes, and test methods.
• Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
• Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.

Skills

Process validation

Quality systems

Statistical analysis

Regulatory compliance

CAPA/NCMR

Education

Bachelor's degree in Engineering/Science/Tech field

Master's degree in Engineering/Science/Tech field

PhD

Tools

Minitab

Job description

Medtronic plc in West Valley City, Utah, is seeking a Senior Quality Engineer for an onsite role with a Monday–Thursday schedule from 3:30 p.m. to 2:00 a.m.

The position emphasizes process validation, quality system execution, and collaboration with engineering and manufacturing teams to ensure compliant, high-quality manufacturing processes. You will lead validation activities, support CAPAs/NCMRs, analyze data with statistical methods, and contribute to regulatory compliance within a regulated