SOZO Brain Center is an international leader in non-invasive neuromodulation, providing innovative, evidence-based treatments for neurological, mental health and chronic conditions. Through clinical neuroscience, research and education, we are committed to improving patients' lives while developing the next generation of healthcare professionals.
About the Job:
As a Medical Devices Manufacturing and Quality Engineer for SOZO Brain Center, you develop a thorough understanding of SOZO's medical-device production processes, monitor outsourced manufacturing and perform final product quality checks. Also, you support the maintenance of the Quality Management System and regulatory documentation, working closely with manufacturing partners and SOZO's regulatory team and specialist advisers.
Duties & Responsibilities:
Manufacturing Oversight
- Observe and learn device assembly, testing and packaging processes, without directly participating in assembly.
- Monitor manufacturing progress and adherence to agreed specifications and procedures, escalating delays or quality concerns.
- Support manufacturing transfer and knowledge sharing between SOZO and its production partners.
Final Quality Control
- Perform final device and kit inspections and testing following approved training, procedures and authorisation.
- Maintain accurate test results, quality checklists, serial-number traceability and shipment verification records.
- Identify and document non-conforming products, hold them pending an authorised decision and support corrective actions.
Quality Management & Regulatory Support
- Support the implementation and maintenance of ISO 13485 quality procedures, controlled documents and audit records.
- Assist with technical documentation, labelling and EU MDR/Swiss MedDO compliance activities under specialist guidance.
- Support the recording and investigation of product complaints, escalating potential safety concerns promptly.
Requirements:
- Degree in Biomedical, Manufacturing, Mechanical Engineering, or a related discipline.
- Relevant experience in medical-device manufacturing, quality assurance or quality control.
- Working knowledge of ISO 13485 EU MD and Swiss MedDO.
- Experience with Swiss MedDO would be an advantage.
- Ability to interpret technical instructions, perform structured product checks and maintain accurate records.
- Strong attention to detail, practical problem-solving and communication skills.
- Availability to work on site in Italy initially and subsequently in Switzerland.
- Fluent English. Italian language and any other language will be considered as an advantage.
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