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VALIDATION AND CALIBRATION ENGINEER [DW2141-03]

Job Title: VALIDATION AND CALIBRATION ENGINEER [DW2141-03]
Contract Type: Permanent
Location: North - Penang
Industry:
Salary: 4000.00 - 5000.00
Start Date: 29 Jan 2021
Reference: en-48441
Contact Name: Daniel Wong
Contact Email: daniel.wong@jac-recruitment.com
Job Published: January 29, 2021 16:14

Job Description

JOB RESPONSIBILITIES

  • Responsible to plan, prepare, execute and follow-up validation master plan.
  • Experience in Validation Protocol, Installation Qualification, Operation Qualification, Performance Qualification and to release Final Validation report for all medical devices, production’s equipment and products.
  • To work in a cross-functional team and independently to accomplish validation project objectives.
  • Responsible to perform daily calibration and verification of instrument.
  • Responsible to communicate and update the validation status to respective personnel and value stream members for mutual understanding.
  • Responsible to train operation team on the functionality, procedure and limitation when handling any production equipment and tools.
  • Responsible to prepare and review calibration and verification report.
  • Responsible for writing validation, calibration and verification of system documents.
  • Serves as technical expert for the validation and calibration / verification process and responsible to ensure compliance to ISO 13485 and AS 9100 standard requirements.
  • Assist in Quality audit process.

JOB REQUIREMENTS

  • Bachelor’s Degree in Engineering or related field; or 2 years of related working experience in Validation, Calibration and Quality; or equivalent combination of education and experience.
  • Good understanding of ISO9001, ISO13485 and AS9100 standard requirements, Quality Management Systems, FMEA and root cause analysis.
  • Good knowledge of validation, calibration and verification process.
  • Good technical judgement and problem solving skills.
  • Good attention to details and statistical skills.