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Quality System Engineer

Boston Scientific · George Town, Penang, Malaysia

Location
George Town
Job Type
Full-time
Posted
June 07, 2026

Job Description

Key Responsibilities:


  • Support implementation of internal quality system requirements and external regulatory standards (e.g., FDA, ISO 13485, cGMP, EU MDR)

  • Drive improvements to procedures and standards to enhance efficiency while maintaining compliance

  • Support and coordinate CAPA and compliance programs, including facilitating CAPA activities across functions

  • Participate in CAPA management activities and global quality system discussions

  • Conduct internal audits to identify gaps, ensure compliance, and drive continuous improvement

  • Support audit readiness, including front-room and back-room activities during external audits and inspections

  • Deliver quality system training and guidance to employees across the site

  • Lead or participate in system and process improvement initiatives using structured problem-solving approaches

  • Identify areas of non-compliance and recommend corre...

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