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Quality Assurance Manager

2 months ago

Malaysia Karex Full time


Quality Assurance Specialist

Join our team as a Quality Assurance Specialist and play a critical role in ensuring the highest standards of quality in our manufacturing processes.

Role Responsibilities
  • Develop and implement quality assurance and sterilization procedures to ensure compliance with regulatory requirements.
  • Establish and maintain the design criteria of the Quality System, integrating it across all levels of the organization.
  • Collaborate with customers and manufacturing teams to establish product and performance standards.
  • Evaluate, measure, and report on the effectiveness of manufacturing processes and the quality of materials and products.
  • Monitor and ensure good hygiene and housekeeping practices are maintained to prevent pre-sterilization microbiological contamination.
  • Approve sterilization validation programs to ensure their effectiveness.
  • Ensure the quality system requirements are effectively established and maintained in accordance with ISO standards.
  • Administer the Audit and Corrective Action Program to identify and address quality issues.
  • Oversee the complaint handling system, reviewing investigations and trends to drive continuous improvement.
Role Requirements
  • Hold a degree in Science or Engineering, with a minimum of 5 years of work experience in the manufacturing industry.
  • Excellent communication skills in English and Bahasa Malaysia, both written and oral.
  • Proficiency in MS Office applications, particularly Excel.
  • Willingness to work in a dynamic environment and adapt to changing priorities.