Experteer Overview
In this role you ensure supplier quality across an international, multidisciplinary environment. You will develop and maintain quality procedures, support KPI analysis, and drive supplier audits and improvements. You partner with R&D, Process Validation, Purchasing, and Regulatory teams to secure robust supplier performance and compliant documentation. This, in turn, helps Enovis deliver clinically differentiated solutions and improved patient outcomes.
Retribuzione / Benefits
- Create and maintain Quality Management System procedures and work instructions
- Manage and collect quality records per QMS procedures
- Analyze supplier quality KPIs and nonconformities trends; perform root cause investigations
- Qualify and oversee suppliers, including conducting audits as auditor
- Support supplier improvement plans after audits and nonconformities
- Evaluate supplier process validation strategies with cross-functional teams
- Communicate with suppliers on product and process quality topics
- Collaborate with R&D to modify technical documentation as needed
- Coordinate with Purchasing to identify new sources
- Assist Post Marketing Surveillance and Incoming Inspection regarding outsourced production issues
- Support Regulatory with supplier process information for registrations
- Assist internal inspections by Certification/Notified Bodies and Authorities
- Recommend corrective actions to minimize nonconformities
- Manage initial sampling with suppliers
Responsabilità
- Bachelor's or Master's degree in Engineering (Mechanical, Management, Biomedical, or Bioengineering preferred)
- Experience in supplier quality assurance in modern manufacturing environments
- Strong Excel and Microsoft Office skills
- Precise and methodical work approach, able to handle multiple tasks
- Team player with good communication in English (min B2); basic German is a plus
- Willingness to travel short-term within Italy and abroad
- Lead Auditor qualification (AICQ-CEPAS, AICQ-SICEV) considered a plus
