Senior Quality Engineer - Medical Device Validation & CAPA

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

Benefits offered by this job

Health insurance

401(k) plan with company match

Tuition assistance

Well-being program

Job summary

Medtronic plc, based at the West Valley City manufacturing facility in Utah, seeks a Senior Quality Engineer to lead process validation activities and drive quality across manufacturing operations. The role emphasizes validating processes, CAPA, and data-driven quality decisions in a highly regulated medical device environment.

The position is on-site with a second shift schedule (Mon-Thu, 3:30 p.m. to 2:00 a.m.).

Qualifications

• Experience in regulated medical device environments.
• Knowledge of CFR requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
• Experience with process validation lifecycle across complex manufacturing processes.
• FDA-regulated medical device manufacturing experience.
• CQE/Lean Six Sigma certification or similar quality credential desirable.

Responsibilities

• Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and 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 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.
• Develop and implement inspection, testing, and evaluation methods to verify product quality and process capability; ensure documentation compliance.

Skills

Process validation

CAPA investigations

Statistical analysis

Quality systems

Manufacturing processes

Education

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

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

Tools

Minitab

Job description

Medtronic plc, based at the West Valley City manufacturing facility in Utah, seeks a Senior Quality Engineer to lead process validation activities and drive quality across manufacturing operations. The role emphasizes validating processes, CAPA, and data-driven quality decisions in a highly regulated medical device environment.

The position is on-site with a second shift schedule (Mon-Thu, 3:30 p.m. to 2:00 a.m.).