Overview

In this role you will lead the quality function to maintain and improve the quality system in line with ISO 9001, ISO 13485, MDSAP and FDA/EU requirements. You will drive cross-functional quality initiatives, supplier quality, and product/service improvements using data-driven methods. The role emphasizes leadership of corrective actions, audits, and continuous improvement projects, delivering measurable quality outcomes. This is an opportunity to shape quality systems in a global healthcare environment and collaborate across departments.

Retribuzione / Benefits

- corporate premio

Responsabilità

- Serve as Core Team Member on cross-functional NPD/servDes teams with focus on quality plans and transfer
- Develop and implement statistically valid sampling plans, DOE, capability studies, SPC and trend analysis
- Lead process and product corrective actions and problem-solving activities
- Review current quality system and implement improvements
- Use data to propose process/product changes to improve quality
- Lead projects on quality system and product/service improvements
- Develop analyses and reports on quality system performance
- Lead supplier audits and corrective actions




- Lead and support internal and external quality system audits
- Instruct colleagues in quality principles and statistical techniques
- Collaborate with other departments on quality issues
- Supervise Quality Engineers and staff in duties and objectives
- Maintain product integrity via nonconforming material/process evaluation and disposition
- Perform other duties as assigned

Requisiti fondamentali

- Minimum 5 years of related Manufacturing/Quality Engineering and/or Quality Systems experience with strong supplier quality experience
- Experience in an ISO-certified environment; medical device or regulated industry preferred
- Experience with supplier qualification and audits, SCAR/CAPA, root-cause investigation, risk management, and supplier performance improvement
- ASQ, QSR or familiarity with QSR/GMP regulations

- Technical leadership
- Cross-functional collaboration
- Coaching and mentoring
- Quality systems and continuous improvement
- Data-driven decision making and metrics analysis
- Statistical techniques (SPC, capability studies, DOE)

📌 Senior Quality Engineer (Roma)
🏢 Steris
📍 Roma