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Medical Equipment Maintenance Validation and Qualification Specialist
14 minuti fa
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 pieno
Retribuzione: €35.000,00 - €40.000,00 all'anno
Disponibilità:
- Dal lunedì al venerdì
Retribuzione supplementare:
- Tredicesima
