Quality Engineering Lead - Medical Devices

STERIS; Roma; On-site; EUR 39,250 - 48,000; Full time

Job summary

STERIS is seeking a Quality Engineering Supervisor to lead a team of quality engineers, technicians and inspectors across multiple production lines. You will drive process and product quality improvements, investigate NCRs, and ensure final QC testing and internal/customer metrics meet targets.

The role collaborates with CI on Lean initiatives and maintains compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211 and EU MDR.

Qualifications

• Bachelor's degree in Engineering required.
• 5–8 years of Quality Engineering experience in regulated industry.
• Experience with QMS (Quality Management System) and supplier quality.
• 3–5 years supervising/leading employees.

Responsibilities

• Lead assigned Quality team focused on manufacturing/servicing quality improvement for key metrics.
• Oversee NCR investigations and bolster production quality and final QC testing.
• Drive Lean and quality improvements with CI resources and ensure regulatory compliance (ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR).
• Establish objectives and develop talent within the team.
• Align quality improvements with supplier strategies and ensure robust process controls.

Skills

Customer focus

Teamwork

Results orientation

Communication

Job knowledge

Leadership

Data analysis

Education

Bachelor's degree in Engineering

Tools

Excel

Visio

Minitab

Word

Job description

STERIS is seeking a Quality Engineering Supervisor to lead a team of quality engineers, technicians and inspectors across multiple production lines. You will drive process and product quality improvements, investigate NCRs, and ensure final QC testing and internal/customer metrics meet targets.

The role collaborates with CI on Lean initiatives and maintains compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211 and EU MDR.