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🥝 Quality Engineer - Medical Devices & CAPA Lead

Boston Scientific Gruppe | batu kawan, Malaysia | Posted June 15, 2026

Job Description

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  • Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
  • Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
  • Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
  • Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
  • Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
  • Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
  • Ensure compliance with Quality Management Systems (QMS) and applicable re...

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