Roles & Responsibilities

Your Role?

As a Senior Quality Engineer, your will be responsible for creating and implementing strategy for quality coordination testing as well as suggesting solutions to identified quality problem. In this exciting role, your scope of duty below.

· Responsible for developing and maintaining of Quality Management System / Procedures / Inspection Instructions across manufacturing sites.

· Implement, maintain and improve ISO 9001 & ISO 13485 Quality Management System.

· Plan and conduct the Internal and External audits.

· Support in qualifying new suppliers and maintain / develop existing supplier performance.

· Liaise and conducting root cause analysis with inter-department / suppliers and customer on CA effectiveness and preventive measure to resolve quality issue.

· Review and maintain internal procedure and documents such as work instruction, quality procedure, process control plan and FMEA.

· Develop standard operating procedures and conduct training for quality inspectors.

· Maintain the equipment calibration system (Internal / External)

· Support for new product launch and raw material First Article approval, oversee the quality of new products from sample build to mass production by building a robust process.

· Supervise and guide junior QA Engineer and team(s) of quality inspectors in performance of daily tasks.

Your Profile?

· Degree in Mechanical, Quality Engineering or Equivalent.

· At least 3 years of QA experience in a Manufacturing environment.

· Experience in Medical devices industry, Optics Manufacturing and Automotive.

· Hands-on experience in supplier qualification & development, internal audit and maintaining ISO 9001 & ISO 13485 system.

· Possess good knowledge in SPC, MSA, FMEA, QC Tools.

· Comprehending Technical Drawings.

· Knowledge of LEAN Six Sigma and 8D Discipline methodology highly desirable.

· Team player who can communicate well with people at all levels.

· Good Spoken and written in English.

· Excellent problem solving skills.