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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 exĂ©cution 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

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