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Quality Engineer

Company

Boston Scientific

Location

Kampung Batu Kawan, Pulau Pinang

Type

Full-time

Key Responsibilities:


  • 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 regulations (e.g....
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