A leading Medical Device company is now searching for a Quality Engineer to be a part of their growing team. The Quality Engineer will work in their manufacturing facility based in the South East.
Lead the Quality engineering activities in conjunction with a cross functional team as required. Develop process risk management documentation with cross-functional support. Develop or assist in development of inspection and test methods per product specifications. Perform test method validations and component qualifications as required. Perform DOE's and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. Provide quality support to inspectors to ensure resolution to issues identified on supplied material. Work with suppliers to ensure robust corrective actions are implemented as required. Participate in supplier audit programme as required. Participate in internal audit and CAPA programmes. Develop robust action plans, projects and verification activities for elimination of potential non- compliance and CAPA related risks, as required. Align quality system with changes in global and corporate quality management standards, policies and regulations. Identify quality systems engineering improvement opportunities and executes through the change management system.
Honours (level 8) Degree in Mechanical/Manufacturing/Production engineering or similar
Knowledge of Reg requirements
Knowledge of cleanroom environmental monitoring
>5 Years' experience in a production environment
>5 years' experience in quality department
>5 Customer Complaints Management experience
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.