Quality Engineering Supervisor

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

Position Summary

We are looking for a candidate that will join our team as a Quality Engineering Supervisor. The Quality Engineering Supervisor leads a team of quality engineers, technicians and inspectors focused on process and product quality improvement for multiple production lines/value streams. This role has responsibility for incoming product/component inspection, NCR investigation, production quality and final QC inspection/testing. The Quality Engineering Supervisor has responsibility for internal and customer facing key metric performance for assigned production lines/value streams. This role is responsible for the hiring, development and overall management of his/her Quality team. This individual develops and manages work assignments, analyzes and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues. The Quality Supervisor works closely with CI resources in the site to drive overall Lean and Quality improvements. In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other regulatory standards, as applicable.

Duties

• Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics.
• Lead assigned Quality team focused on internal production quality by improving component and process non conformances; production line DPU (defect per unit); production FPY (first pass yield).
• Lead assigned Quality team to improve customer facing and internal product/service and process quality key metrics through robust data analysis and improvement/problem solving projects.
• Ensure robust production and process controls that are in alignment with production and Lean strategies.
• Align production product and service quality improvement to supplier improvement strategies and tactics.
• Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy.
• Lead the Team’s talent development processes and knowledge development.
• Assume other duties as assigned.

Education Degree

Bachelor's Degree in Engineering General

Required Experience

• 5-8 years of Quality Engineering experience.
• 5-8 years of experience in healthcare, medical device or other regulated industry preferred.
• 5-8 years of experience working within a regulated or certified Quality Management System required.
• 3-5 years of experience with supplier quality.
• 3-5 years of experience in Lean methods.
• ASQ, QSR, or familiarity with QSR/GMP regulations preferred.
• 3-5 supervising/leading employees.

Skills

• Customer Focused: Demonstrates a "Customer first" mindset. Responds with a sense of urgency.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions.
• Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
• Communication: Constructs clear written communication. Keeps manager and co-workers informed.
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab and Word.
• Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction.
• Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements.

Compensation

• Salary Range: 39.250€ - 48.000€
• NCBA: Chimica, Concia e Settori Accorpati, CONFAPI
• Bonus: This position is eligible for corporate bonus.

STERIS strives to be an Equal Opportunity Employer.