23 ott - Pomezia
Steris
Overview
In this role you will lead a Quality Engineering team focused on improving process and product quality across multiple production lines. You will manage inspection, NCR investigations, and QC testing while driving Lean and Quality improvements with cross-functional teams. You’ll ensure compliance with ISO 9001, ISO 13485, MDSAP, FDA regulations, and EU MDR, influencing both internal and customer-facing quality metrics. This position offers ownership of team development and data-driven problem solving to reduce nonconformances and drive performance.
Retribuzione / Benefits
- corporate premio
Responsabilità
- Lead and develop the Quality team to improve internal production quality metrics (DPU, FPY) and customer-facing quality outcomes
- Drive robust data analysis and improvement projects to reduce nonconformances and improve process controls
- Align quality improvements with Lean strategies and supplier quality initiatives
- Set and manage objectives for individuals and the team in line with the Quality strategy
- Support Quality System compliance across ISO 9001, ISO 13485, MDSAP, FDA and EU MDR requirements
- Contribute to talent development, training, and performance management of team members
- Perform nonconformance investigations and guide problem-solving using established methodologies
- Collaborate with CI resources to sustain Lean and quality improvements
Requisiti fondamentali
- 5-8 years of Quality Engineering experience
- 5-8 years in healthcare, medical device, or regulated industries preferred
- 3-5 years in supplier quality
- 3-5 years in Lean methods
- ASQ, QSR, or familiarity with QSR/GMP regulations preferred
- 3-5 years supervising/leading employees
- English language required for communications with non-local teams
- Customer focus
- Teamwork
- Initiative/Leadership
- Quality management system
- ISO 9001
- Lean manufacturing
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