REQUIREMENTS : Education and Experience: Bachelor's Degree in Science/Engineering/Manufacturing related fields.Certified in Quality Auditor (ASQ CQA/RABQSA/IRCA/EOQ). Either of the listed will satisfy the requirement.Certified in Lean Six Sigma Black Belt, CQA and CQM.Must be able to communicate fluently (written and oral) in Bahasa Malaysia and English.Minimum 5 – 8 years' experience in a manufacturing environment on Production, Quality Assurance or Manufacturing Engineering.Exposed to Quality Engineering tools and techniques, e.g. SPC, QC tools DOE, ANOVA and Minitab.Good track record that consistently go beyond and exceed goals and minimum 5 to 8 years of relevant experience or a combination of equivalent education and experience.Knowledge and Skills: Systematic and analytical - ProficientMotivational skill - ProficientPeople-oriented personality - ProficientDeadline-oriented - ProficientCommunication Skills – ProficientComputer Skills – ProficientCritical thinking and decision-making skills – ProficientLeadership skill – ProficientTechnical Writing skills - Proficient RESPONSIBILITIES: Responsible for overall management of QA Activities in manufacturing (in-process and releasing, qualification, audit, customer complaint and etc).Liaise with respective cell leaders and associates on matters related to quality as to ensure that products are manufactured to requirements.Assure that all quality control functions are performed effectively to meet production schedule through planning and good communication.Lead quality engineer (manufacturing) to ensure proper implementation and maintenance of a quality system in compliance with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations.Assist and support in regulatory and customer audits as needed. May conduct internal and supplier audits.Support the implementation of new products and ongoing production of existing products, processes, and changes by developing and maintaining quality plans, approval of validation plans and protocols, inspection methods, and work instructions.Support and lead Quality Engineer in the investigation, documentation, root cause, and identification of corrective action activities of customer complaints in collaboration with cross functional teams.Conduct training regarding Quality Requirements.Review and support rework instructions (including verification or validation of instructions).Drive product and non-product process nonconformance (NCMR) including aging and is a member of the cross-functional investigation, root cause, and corrective action team to resolve nonconformances.Perform continuous Quality evaluation and trend analysis on product quality issues, resolve quality problems and initiate corrective action with other departments as required.Lead and motivate subordinate to achieve the highest level of proficiency.Provide leadership and training on statistics and analytical tools to facilitate employee involvement in problem-solving or quality improvement activities.Participate or lead quality improvement activities pertaining advise quality trend and customer complaints.Other duties as assigned.