Requirements: English
Company: Orthofix
Region: Bussolengo , Veneto
We offer an interesting opportunity to join our Quality Operations team, based in Bussolengo (VR) as Junior Supplier Quality Engineer , reporting to the Supplier Quality Engineer Supervisor.
In this position you will be in charge the support activities for supplier performances management, supplier audit, production flows validation and monitoring. Specifically, you will deal with approval of products supplied (PPAP, FAI), monitoring and management of suppliers performances (KPI, SCAR management) and supplier audits planning and management.
What will your contribution be?
- Supplier Qualification: Collaborate with International Supply Chain to select, qualify, and develop new Suppliers, ensuring they meet the required quality standards.
- Supplier Audit: Conduct audits at Supplier facilities to evaluate their Quality Management Systems, ensuring compliance with applicable regulations such as ISO 13485 and FDA 21 CFR Part 820.
- Supplier Monitoring: Use statistical techniques and Six Sigma methodologies to analyze Supplier processes, identify areas for improvement, and implement corrective and preventive actions.
- External Process Validation: Support Suppliers in the development and validation of manufacturing processes, including the qualification of tools and testing methods, to ensure the quality of supplied components.
- Supplier non-conformities and SCAR management: Manage supplier-related non-conformities, coordinate root cause investigations, and ensure the implementation of effective corrective actions
What are we looking for?
- Masters degree in mechanical or biomedical engineering or similar is preferred
- At least 2 years of experience in quality, manufacturing, research and development, or process engineering roles, preferably in the medical device sector or other highly regulated industries.
- Excellent English written and spoken required
- Familiarity with applicable regulations and standards, such as ISO 13485 and ISO 9001
- Experience with statistical analysis techniques, process validation (IQ, OQ, PQ), and quality control methodologies.
- Ability in conducting root cause analysis and leading non-conformity investigations.
- Basic knowledge of technical design, process audit, measurement analysis (MSA, RR), problem solving (8D, FMEA), Control Plan.
- Good knowledge of Microsoft Office
What soft skills are we looking for?
- Excellent written and oral communication abilities, with experience working effectively in cross functional teams.
- Problem solving
- Ability to interact with operational department
What will you find?
- Friendly, warm, and innovative atmosphere
- Healthy, inspiring, and international and inclusive work environment
- Training and development opportunities
- Competitive reward packages
- Social and company events
- Wellbeing initiatives (welfare)
- Canteen
- Benefits (Pension Fund- Health Insurance)
What we offer?
- This is a full-time job
- The contract is a permanent contract
- Salary package range: 32.000/35.000 euro*
*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person