Our client, leading MedTech startup that specializes in the development of innovative, biodegradable prostheses for natural breast reconstruction, is looking for a **Medical Equipment Maintenance Validation and Qualification Specialist** **Main Responsibilities**
- Ensures the continuous efficiency, functionality, and safety of production and R&D; equipment, machinery, and tools, in compliance with internal procedures and by liaising with external companies when necessary and authorized
- Develops an appropriate maintenance strategy to ensure production continuity and the desired levels of equipment/instrument availability
- Manages routine and extraordinary **maintenance** of equipment and machinery, in accordance with procedures
- Collaborates in defining and monitoring maintenance-related KPIs
- Manages the implementation of company software, their validation, and the monitoring of related licenses
- Provides prompt intervention in the event of malfunctions or anomalies in the production process and R&D; equipment and machinery, with the goal of minimizing downtime
- Proposes initiatives aimed at optimizing equipment and machinery, supporting company functions in identifying and implementing improvement actions
- Monitors and ensures the continuous efficiency of safety and alarm devices to prevent injuries and damage to workers, machines, and equipment
- Participates in preparing the company for inspections by Competent Authorities and contribute to their successful outcome by collaborating on the implementation of any corrective actions




- Identifies actions to ensure continuous updates and role adequacy in relation to new required knowledge
- Drafts and updates Standard Operating Procedures (SOPs) and written operating instructions regarding the maintenance of company facilities, equipment, and machinery
- Executes and manages validation activities related to machinery, utilities, and instruments under the supervision of the Chief responsible and in collaboration with relevant company functions; oversee the **qualification and validation** of new equipment, machinery, and tools, particularly ensuring the correct execution of required functionality and calibration tests, as well as pre-startup and startup trials
- Collaborates in the management of non-conformities within their area of responsibility
- Collaborates in the management of preventive and corrective actions within their area of responsibility **Requirements**: - 2+ years of experience in the manufacturing environment
- Diploma as an industrial or technical expert in electrical or mechanical industries, or a degree in engineering disciplines
- Practical experience in the use and maintenance of production and laboratory tools for chemical and biological activities
- Good computer skills
- Knowledge of quantitative and qualitative approaches, as well as the organizational, operational, and technical aspects of businesses
- Ability to work in a team. Precision, reliability, and the ability to work independently **Location**: Milan Contratto di lavoro: Tempo completo Retribuzione: €35.000,00 - €40.000,00 all'anno Disponibilità: - Dal lunedì al venerdì Retribuzione supplementare: - Tredicesima

📌 Medical Equipment Maintenance Validation and Qualification Specialist (Milano)
🏢 Amygdal
📍 Milano