Senior Quality Engineer: Medical Devices Process Validation

Medtronic; North Haven, Northern (CT, KY); Hybrid; 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

Job summary

Medtronic plc in North Haven, CT is seeking a Senior Quality Engineer to lead process validation and quality system execution in a regulated medical device environment. You will collaborate with manufacturing and engineering to uphold quality standards and drive continuous improvement, while mentoring staff.

The role emphasizes validation lifecycle leadership, analysis of quality data with Minitab, and CAPA/NCMR activities to ensure compliant, reliable manufacturing processes.

Qualifications

• Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience or Master's with 2+ years.
• Experience executing process validation across full lifecycle.
• Knowledge of CFR requirements and GMP in regulated environments.

Responsibilities

• Lead process validation activities across the full validation lifecycle (planning, protocol, execution, analysis, reporting).
• Partner with manufacturing and engineering to implement quality standards and process requirements.
• Drive CAPA and NCMR activities to resolve quality issues and prevent recurrence.
• Analyze quality and process data using statistical methods for risk-based decisions.
• Develop inspection, testing, and evaluation methods to verify product quality.
• Support qualification/validation of equipment, processes, and test methods.
• Ensure documentation and manufacturing practices comply with regulations.
• Mentor quality and engineering colleagues on complex projects.

Skills

Process validation

CAPA

Statistical analysis

Quality systems

Risk analysis

Minitab

FDA-regulated environment

Education

Bachelor's degree in Engineering/Science

Master's degree in Engineering/Science

PhD in a technical field

Tools

Minitab

Job description

Medtronic plc in North Haven, CT is seeking a Senior Quality Engineer to lead process validation and quality system execution in a regulated medical device environment. You will collaborate with manufacturing and engineering to uphold quality standards and drive continuous improvement, while mentoring staff.

The role emphasizes validation lifecycle leadership, analysis of quality data with Minitab, and CAPA/NCMR activities to ensure compliant, reliable manufacturing processes.