1 to 3 of 3 Permanent ISO 13485 Jobs in the East Midlands

for a Quality Manager to join our medical device client in Northamptonshire on a 6 month Fixed Term Contract. Applicants should be experienced with ISO 13485, validation and verification and MDR would be advantageous. Client Details Our client are a regulated manufacturing and distribution company based in the … step into management. Description Key Responsibilities but not limited to: Creation and control of quality documents (SOPs, WIs, records etc) Management Representative responsible for ISO 14385 certification and maintaining the effectiveness of the Full Support Healthcare QMS Maintenance and communication where required of technical documentation Investigate and report on … to be sterilised Verification and Validation of new products and product range extensions.Profile 5+ years' experience in a healthcare quality and regulatory compliance role. ISO 13485 auditor. Working knowledge of ISO 13485, UK and EU MDR. Demonstrable technical writing capability. Excellent attention to detail. Interpersonal and more »

report Skills and experience required: + Degree in relevant discipline + Proven experience in medical device development + Previously worked to relevant quality standards – ISO 13485 + Experience in prototyping and testing + Strong 3D CAD skills + Experience in different manufacturing processes - injection moulding The salary will more »

functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO 13485, and IATF 16949, is a plus Experience working with suppliers and customers more »