Quality engineering supervisor

STERIS

Pomezia

In loco

EUR 39.000 - 48.000

Tempo pieno

4 giorni fa
Candidati tra i primi
Generatore di candidature

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Corporate bonus eligibility

Descrizione del lavoro

STERIS Italy in Pomezia is seeking a Quality Engineering Supervisor to lead a team of quality engineers, technicians and inspectors focused on process and product quality improvements across production lines.

You will drive data analysis, manage NCR investigations, assure compliance with ISO 9001, ISO 13485, MDSAP and FDA/EU regulations, and develop talent within the quality team while aligning with Lean strategies.

Competenze

  • Bachelor's Degree in Engineering General.
  • 5-8 years of Quality Engineering experience.
  • Experience in healthcare/medical device or other regulated industry preferred.
  • 3-5 years supervising/leading employees.
  • Experience with supplier quality and Lean methods.
  • ASQ/QSR familiarity or GMP knowledge is a plus.

Mansioni

  • Lead assigned Quality team focused on overall manufacturing/servicing quality improvement.
  • Oversee NCR investigations and internal/external quality processes.
  • Drive data analysis to improve key quality metrics and process control.
  • Ensure compliance with ISO 9001, ISO 13485, MDSAP, FDA and EU MDR.
  • Develop talent and align quality initiatives with Lean strategies.

Conoscenze

Customer Focus
Teamwork
Results Orientation
Communication Skills
Data Analysis
Leadership

Formazione

Bachelor's Degree in Engineering General

Strumenti

Excel
Visio
Minitab
Word

Descrizione del lavoro

Job Type: Full-Time

Category: Quality

Posted Date: 2026-07-13

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/values 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
  • Bonus: This position is eligible for corporate bonus .

STERIS strives to be an Equal Opportunity Employer.

Skills
  • quality engineering
  • quality management system
  • qsr
  • iso 13485
  • minitab
  • 21 cfr
  • quality issues
  • visio
  • eu
  • gmp regulations
  • problem solving methodologies
  • yield
  • word.
Quality engineering lead - medical devices
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