- Responsible for leading projects related to changes on Latina Site products.
- Works with Supplier Changes and Notices in resolving issues, related to supplied resins, components and materials used for production.
- Work cross-functionally with R&D, Quality and or Design Assurance to resolve technical issues, including developing and driving working solutions and comprehensive mitigation plans.
Roles and Responsibilities
- Resolving product and component needs and issues to ensure continuity of supply for existing Products of Latina Site.
- Working with the Supplier Change Notification process and Supplier Quality in any issues, changes, or updates to supplied resins, components and materials used for production in Latina Site.
- Working with R&D, Quality, Regulatory, Design Assurance and Plant Engineering to test components and or product to document and make changes or updates to ICU product documentation.
- Preparing and executing Change Management documentation to include Commodity Specs, Drawings, Change Management Control plans and Design and Development Plans as needed to ensure continuity of components, materials, and packaging materials.
- Communication with management to provide updates on project status and or contingency plans to ensure continuity of supply of components and materials used for on-market product.
- Coordinate with ICU groups to prepare and execute Validations for Medical Packaging and Accelerated Aging Studies.
- Prepares presentations, graphs, plans, forms, reports, etc. or any other document that is required according to the nature of its activities.
- Follows the standard operating procedures, rules and regulations established by entities related to the manufacture of medical products.
- Risk management documentation updates e.g. Hazard Analysis, dFMEA, pFMEA, Test method validations, scrap reduction and process optimization / validation IQ,OQ PQ etc.
- Bachelor’s degree in Science or Engineering.
- Minimum of 3 years in the manufacture industry.
- Communication skills with internal and external suppliers and ICU management.
- Ease of interpersonal relationships and methodical problem solving.
- Strong command of English Language.
- Minitab use for Statistics and Data Analysis.
- Microsoft Project.
- Ability to read technical specifications, drawings, and understand testing standards.
- Working knowledge of CAD systems ideally SolidWorks, including tolerance stack up analysis.
The position is located in Latina, Italy.