ISO 14971, ISO 13485, FDA regulations, FMEA, RCA, Medical Devices, Validation, Quality controlWe are seeking a qualified Production Quality Manager to join our team and ensure the delivery of high-quality products while maintaining compliance with industry standards. The ideal candidate will have a technical or engineering background and a minimum of 5 years of experience in a manufacturing or operations role, with a focus on leading quality and compliance processes. They should possess expertise in risk management, including FEMA, as well as familiarity with standards such as BS EN ISO 9001:2015 and BS EN ISO 13485:2016. Additionally, experience in conducting audits, knowledge of EMC requirements, and proficiency in tools like SharePoint, Confluence, and Jira are desirable.