Responsibilities Job Description Summary Responsible for Quality Engineering Activities Job Description Responsible for Process Validation and PFMEA documentations Ensure compliance to BD Corporate procedure, Division procedure and Bard Sdn. Bhd. procedure. Review process validation data generated and performed statistical analysis where appropriate. Be the protocol originator for component qualification, ship testing, accelerated aging, real time stability Plan, organize, coordinates and lead projects relating to process, manufacturing and quality to support the requirements of the Quality Assurance System. Perform continuous Quality Control evaluation and trend analysis on product quality issues, resolve quality problems and initiate corrective action with other departments as required. Perform investigation and root cause analysis for process and product non-conformances. Assist the Quality Unit Manager in executing special project or assignment.