Leading manufacturer and supplier of medical devices and products is seeking a Quality Engineer to support and maintain the quality management system for ISO13485 and related ISO/compliance activities in the business. This is a permanent role offering excellent development prospects.
The Quality Engineer will lead auditing for IS013485 auditing activity and maintain the Quality Management System across the business including maintenance of all technical files, setting of verification protocols using FMEA processes, creating Quality Control Plans and risk management strategy for the quality department.
The Quality Engineer will create the inspection criteria for the Production department, support quality control of the supply chain, implement containment and corrective actions for quality issues and support customers with any issues that arise.
You will train and mentor internal staff to support ISO audits including ISO9001 and ISO13485 and support minor engineering change note updates in the system when required.
The Quality Engineer will possess a proven record in manufacturing quality particularly ISO auditing to ISO13485 and ISO9001. You will have experience in maintaining and developing a Quality Management System. You will be conversant with quality engineering tools used in a manufacturing environment and able to work at the pace required to support often high production volumes.
The Quality Engineer will be well versed in FMEA processes, root cause analysis and possess a pragmatic approach to implementing compliances within a busy multi-site operation.
This is a day`s based position working, Monday to Friday, on site 0800-1700 hrs with an earlier finish on Fridays.
To apply, please contact James Colley with a current CV via email.