Process Validation Engineer - Additive Manufacturing

Are you a highly skilled Engineer who is dreaming of a job with a real impact on patients ’lives? Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our manufacturing processes? If yes, come to join our Process Validation team

(Additive Manufacturing)

Together we can shape the future of the healthcare. As Process Validation Engineer you will participate to the qualification-validation strategy for the processes and activities for which you are responsible (internally and externally). You will work in close collaboration with R&D, Operations and RA departments and with sub-contractors to qualify their processes. Your main responsibilities will be:

• As Subject Matter Expert (SME) in Additive Manufacturing for Medical Devices

• 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

• As a key contributor to the quality roadmap across the product development lifecycle:

• Participating to DHF completeness

• Defining, Planning , executing and reviewing all validation/verification activities

• Managing all changes including impact assessment