Senior Quality Engineer: Process Validation & CAPA Lead

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

Benefits offered by this job

Health, Dental and vision insurance

401(k) plan with employer match

Tuition assistance/reimbursement

Life insurance

Disability leave

Employee Stock Purchase Plan

Job summary

Medtronic plc in the United States seeks a Senior Quality Engineer to lead process validation, CAPA and NCMR activities within a regulated medical device environment. This onsite role partners with manufacturing and engineering to ensure compliant, high-quality processes and products.

Based at the West Valley City, Utah facility, the position emphasizes data-driven decision making, mentoring colleagues, and adherence to quality systems and CFR requirements.

Qualifications

• Experience in regulated manufacturing environments, with emphasis on quality engineering and validation processes.
• Familiarity with CFR requirements and quality systems in medical device or pharmaceutical settings.
• ASQ CQE, Lean Six Sigma or similar certification is preferred.

Responsibilities

• Lead process validation activities across the full lifecycle from planning to monitoring.
• Collaborate with manufacturing and engineering to enforce quality standards and process controls.
• Drive CAPA and NCMR investigations to prevent recurrence and improve quality.

Skills

Process validation

CAPA

NCMR

Statistical analysis (Minitab)

CFR knowledge

CQE/Lean Six Sigma

Education

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

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

PhD

Tools

Minitab

Job description

Medtronic plc in the United States seeks a Senior Quality Engineer to lead process validation, CAPA and NCMR activities within a regulated medical device environment. This onsite role partners with manufacturing and engineering to ensure compliant, high-quality processes and products.

Based at the West Valley City, Utah facility, the position emphasizes data-driven decision making, mentoring colleagues, and adherence to quality systems and CFR requirements.