Lowongan Kerja PT. AMTEK ENGINEERING BATAM

PT. AMTEK ENGINEERING BATAM
(Kawasan Industri Cammo Block E No. 1 Batam, Indonesia)

WE'RE HIRING!
QA ENGINEER
(MEDICAL DEVICES)

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:

• Willing to work in Batam, Kepulauan Riau.
• 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.

for interested and qualified candidates, please send your application to email:
recruitment.batam@amtek.com.sg