Senior Quality Engineer: Process Validation & CAPA (Utah)

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) and employer match

Paid time off

Job summary

The Senior Quality Engineer at Medtronic plc will provide quality engineering support for manufacturing with a focus on process validation and quality-system execution. You will partner with engineering and manufacturing teams to ensure compliant, effective processes that drive product quality and regulatory compliance in a highly regulated medical device environment.

Based at the West Valley City facility, this on-site role requires working Monday through Thursday, 3:30 p.m. to 2:00 a.m.

Qualifications

• Minimum 4+ years in engineering or quality roles for bachelor’s degree.
• Experience leading process validation in regulated manufacturing.
• Familiarity with CFR requirements and quality systems.
• Knowledge of CAPA, NCR, NCMR activities and corrective actions.

Responsibilities

• Lead process validation across full lifecycle, including planning, protocol, execution, analysis and reporting.
• Partner with manufacturing and engineering to implement quality standards and controls.
• Drive CAPA and nonconforming material investigations to resolve issues.
• Analyze quality data to support risk-based decisions and continuous improvement.
• Support qualification/validation of equipment, processes and test methods.
• Mentor colleagues and provide technical leadership on complex projects.

Skills

Process validation

CAPA

Statistical analysis

FDA/regulated environment

Quality engineering

Minitab

Education

Bachelor's degree in Engineering/Science

Master's degree in Engineering/Science

PhD (optional)

Tools

Minitab

Job description

The Senior Quality Engineer at Medtronic plc will provide quality engineering support for manufacturing with a focus on process validation and quality-system execution. You will partner with engineering and manufacturing teams to ensure compliant, effective processes that drive product quality and regulatory compliance in a highly regulated medical device environment.

Based at the West Valley City facility, this on-site role requires working Monday through Thursday, 3:30 p.m. to 2:00 a.m.