Lowongan QA Manager di PT Amtek Engineering Batam

Responsibility:

• Manage all aspect of QA functions and ensure both internal and customer’s KPIs are met.
• Identify gaps and risk of QMS and recommend improvement actions to management & lead the execution's with management support.
• Responsible to handle customer quality as key contact point focusing on customer specific requirements.
• Monitor customer scorecard performance and establish improvement plan to achieve customer targets.
• Update KPI performance monthly and drive for continuous improvement actions to meet all KPIs.
• Review and Manage all Customer specific requirement and integrate into QMS.
• Manage a team of Quality engineers / Staff from Quality engineering, QC functions - IQC, IPQC, OQC, Measurement and Calibration functions.
• Monitor all internal quality performance issues as well as supplier / subcont quality related issues and report to management periodically.
• Attend and conduct monthly quality meeting internally as well as externally for any customer compliant.
• Manage all Quality related matters – New Project as well as existing product for any engineering changes.
• Manage and maintain internal QMS to meet ISO/IATF standards and customer’s requirements.
• Manage internal audits – system, process, product, LPA as required by QMS or customer. Follow up with all CAR to ensure 100% closure.
• Involve in all QA related activities such as management review, SPC, MSA, CP, PFMEA, PPAP, APQP, Calibration, DCC, and internal / external audits by customers or third parties.
• Conduct training to all process owner on Customer Requirements, QMS and other QC tools.
• Perform management and administration responsibility of Quality team.
• Maintain quality system in compliance with Medical Device Directive and relevant EMEAA regulations.
• Ensure QMS compliance to ISO 13485 and other applicable medical device standards at all times.
• Maintain compliance to factory operations on EU-MDR, Prop-65, POP and Medical Devices Cleanroom Standard requirements as applicable for medical devices.

Requirements:

• Willing to work in Batam, Kepulauan Riau.
• Degree in Engineering background or equivalent.
• Knowledge of Metal Stamping and secondary processes – molding, plating, coating, welding, polishing and/or heat treatment. 
• Good communication skill in English
• Good management skill of QA operation with reference to ISO14001 / ISO9001 / IATF 16949 / ISO 13485 system requirements.
• Certified Internal Auditor to ISO9001 / ISO14001 / IATF16949 / ISO13485 standards is a must.
• Certified auditor for CQI, VDS standards will be added advantage.
• Good problem-solving skills, logical and analytical mindset, i.e. good skill in 7QC tools, 8D methodology, 5-why analysis, SPC, LEAN and 6-Sigma.
• 6-Sigma Green or Black belt qualification is added advantage.
• Familiar with Automotive Quality Management System and experience in participation in APQP system in new product development and Process Validation.
• Competent in using computer and report writings, Microsoft Office and Web-based system.