Job Details

Description :

• To act as cross function team member to review quality requirements for new projects’ RFQ feasibility study, DPR, DFMEA and Tool DFM.
• To establish medical device files for new products in compliant with ISO13485, US FDA and other authorities' audit.
• To establish quality inspection criteria including product reliability and verification test method are in accordance to design requirements.
• To monitor and ensure project team and suppliers practise PPAP activities according to IATF 16949 procedures.
• To participate in supplier development program and conduct product, system and process audit at supplier premises.
• To lead First Article qualification, test and verification and SPVR approval process.
• To lead periodic process audit on quarterly basis or as and when it is necessary.
• To ensure customer product quality requirements and environmental related substances are fulfilled accordingly.
• To conduct training for operational QA personnel on product quality requirement.
• To liaise with customer on all quality issues and improvement activities during product development stage.
• To document product and process changes between internal NPI team and customer.
• To comply with the ISO9001, ISO14001, IATF16949, ISO13485 and OHSAS18001 requirements. 

Requirements :

• Degree in any Science or Engineering disciplines or equivalent.
• Minimum 2 years working experience in quality assurance and system pertaining to NPI (New Product Introduction) in a manufacturing environment.
• Willing to travel.
• Strong analytical, problem-solving and decision-making skills.
• Good interpersonal and communication skills, both verbal and written.
• Able to lead / coordinate or provide guidance to team for continuous improvement.
• Qualified as internal auditor for ISO9001, ISO14001, ISO13485 and IATF16949.