Sr Production Scientist

Our client is seeking a Senior Production Scientist to lead production activities for IVD and other products, ensuring compliance with ISO13485, UKCA, and EU IVDR requirements. The role involves developing manufacturing and QC plans, maintaining equipment under ISO13485 QMS, contributing to ISO13485 certification, and participating in internal and external auditing. The ideal candidate must have experience in an industrial, ISO13485-certified lab environment, calibration and maintenance of scientific equipment, and knowledge of EU IVDD/IVDR regulations. An applied analytical science or physical chemistry degree (or equivalent professional experience) is essential, along with specific experience in ISO13485 industrial laboratory production and compliance to ISO13485 QMS standards. Strong interpersonal and communication skills, the ability to plan and organize workload effectively, and experience with spectroscopy-based techniques are also required.

• Experience in production environment within an ISO13485 lab
• Understanding of QC processes and batch release
• Proven ability to maintain lab equipment
• Training in EU IVDD/IVDR regulations
• Interpersonal and communication skills

The successful candidate will join a dynamic team and have the opportunity to contribute to the company's ongoing scientific activities. This role offers the chance to work in a cutting-edge environment and make a real impact in the field of medical diagnostics.