Lowongan Quality Engineer (Medical Devices) di PT Amtek Engineering Batam

Quality Engineer (Medical Devices) will report directly to the Quality Manager and will be responsible for all activities relating to Medical Devices Product / Process quality : ISO 13485 QMS compliance, New Product Introduction (NPI), Quality Engineering & Control, Medical Devices Supplier Quality Management, Medical Product Quality Assurance and Customer Field Return Management, Regulatory Reporting (if any)

Responsibilities : 

• Manage all aspects of QA functions related to Medical Devices both within the company & with customer’s inorder to ensure that KPIs are met.
• Identify gaps and risk of in operations against ISO 13485 QMS and recommend improvement actions to management & lead the exécution with management support.
• Responsible to handle customer quality as key contact point focusing on Medical customer specific requirements.
• Monitor customer scorecard performance and establish improvement plan to achieve Medicaal customer targets.
• Review and Manage all Customer specific requirement and integrate into QMS.
• Manage / guide a cross functional team from multiple processes to ensure that medical devise part operations are meeting the respective customer requirements.
• Monitor all internal quality performance issues as well as supplier / subcon quality related issues of medical products and drive for improvement actions.
• Involve in New Projects for all new medical device parts as well as in change management for existing products.
• Manage internal audits – system, process, product, LPA as required by QMS or customer. Follow up with all CAR to ensure 100% closure.
• Oversee all medical devices quality assurance related activities (including SPC, MSA, CP, PFMEA, PPAP, APQP, and internal / external audits by customers or third parties) and ensure to achieve the desired results.
• Conduct training to relevant process owner on Customer Requirements, QMS and other QC tools.
• Maintain quality system in compliance with Medical Device Directive and relevant EMEAA regulations.
• Maintain compliance to factory operations on EU-MDR, Prop-65, POP and Medical Devices Cleanroom Standard requirements as applicable for medical devices.

Requirements : 

• Diploma/Degree in Engineering (graduate from in Engineering will be advantage).
• At least 10 years Quality Engineering experience with minimum 7 years of Medical Devices Manufacturing Experience.
• Knowledge of Metal Stamping and secondary processes – molding, plating, coating, welding, polishing and/or heat treatment. 
• ISO 13485 certified auditor
• 6-sigma Black or Green belt qualified
• VDA / CQI certified auditor
• Good communication skills in English & Bahasa.