Spineart

Sales

• Business development
• Identify, prospect and convert new clients
• Develop existing accounts
• Build and deploy a territorial business plan
• Ensure a high level of customer satisfaction

Sales Manager – Medical Devices

Engineer

• Participate to the qualification-validation strategy for the processes and activities for which you are responsible (internally and externally)
• Work in close collaboration with R&D, Operations and RA departments and with sub-contractors to qualify their processes
• Managing and monitoring Additive Manufacturing qualification activities, including environmental monitoring and requalification
• Coordinating/executing validation activities (IQ/OQ/PQ) for equipment, utilities, and cleanroom systems
• Leading investigations, root cause analysis, CAPA, and non-conformity resolution linked with clean room environment
• Ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745, and internal quality systems
• Analysing quality metrics and identifying opportunities for continuous improvement
• Creating, Reviewing and approving quality documentation, SOPs, protocols, and reports
• Interacting with auditors
• Collaborating with Production, Engineering, Regulatory Affairs, and suppliers
• Participating to DHF completeness
• Defining, Planning, executing and reviewing all validation/verification activities
• Managing all changes including impact assessment

Sales Manager – Medical Devices

Process Validation Engineer – Additive Manufacturing