Quality Assurance Executive

Sungai Petani, Malaysia

Job Description


Requirement

  • To ensure implementation and compliance with the requirement of documented quality management system that meets ISO13485 standard and other regulatory standard as applicable
  • Coordinate in preparation of different types of regulatory submission to competent authorities for product registration
  • Organize and manage QA/Lab department and ensure required training is carried out and availability of resources
  • Involve in document and record control, risk management, post market surveillance, nonconformance/CAPA
  • Involve in document and record control, risk management, post market surveillance, nonconformance/CAPA management, change control, supplier quality, manufacturing quality, calibration, and data analysis
  • Authorise COA, COC and/or COI and other relevant record for product release
  • Support marketing on label changes and marketing material review as needed
  • Keep abreast of industry regulatory news and update on guidelines, standards etc and ensure that all in-house systems and procedures are updated, revised and modified to meet the requirements
  • Arrange sample for routine sterilization dose audit and obtain approval on dose audit report
  • Prepare, review and revise procedure, technical report and other document as per QA documentation requirement
  • Any other jobs as directed by superior or Management
  • Education : At least Diploma / Degree in any related field
  • Experience : Preferably 1-2 Year of working experience in related field
  • Skills : Analytical skill, Microsoft Excel, English, Malay


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Job Detail

  • Job Id
    JD934971
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Sungai Petani, Malaysia
  • Education
    Not mentioned