Senior Quality Engineer - Process Validation Leader

Medtronic plc; West Valley City (UT); Presencial; USD 98.000 - 148.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental and vision insurance

Health Savings Account

401(k) plan with employer contribution

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Simple Steps well-being program

Descripción de la vacante

Medtronic plc in Utah is seeking a Senior Quality Engineer to join the Operations Quality team in West Valley City. This onsite role focuses on process validation, quality system execution, and collaboration with manufacturing and engineering to ensure compliant, high-quality processes.

The position emphasizes CAPA, data analysis, and mentorship within a highly regulated medical device environment, offering growth and impact across global healthcare technology.

Formación

• Bachelor’s degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience.
• Master’s degree with 2+ years of engineering and/or quality experience; PhD is considered.
• Experience leading process validation activities for complex manufacturing processes in regulated environments.
• Experience with FDA-regulated medical device/pharmaceutical manufacturing.
• Knowledge of CFR requirements, engineering drawings, machining, chemical processing, packaging, and sterilization.
• ASQ CQE, Lean Six Sigma, or similar quality certification.
• 2+ years of experience executing process validation across the full lifecycle.

Responsabilidades

• Lead process validation activities across the full validation lifecycle.
• Partner with manufacturing and engineering to develop and maintain quality standards.
• Drive CAPA and NCMR activities to resolve quality issues and prevent recurrence.
• Analyze quality and process performance data using statistical methods.
• Develop 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 regulatory compliance; mentor colleagues.

Conocimientos

Process validation

Quality engineering

Statistical analysis (Minitab)

FDA CFR Knowledge

CAPA investigations

Quality systems

Risk-based decision making

Educación

Bachelor's degree in Engineering, Science, or technical field

Master's degree in Engineering, Science, or technical field

PhD.

ASQ CQE or Lean Six Sigma certification

Herramientas

Minitab

Descripción del empleo

Medtronic plc in Utah is seeking a Senior Quality Engineer to join the Operations Quality team in West Valley City. This onsite role focuses on process validation, quality system execution, and collaboration with manufacturing and engineering to ensure compliant, high-quality processes.

The position emphasizes CAPA, data analysis, and mentorship within a highly regulated medical device environment, offering growth and impact across global healthcare technology.