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Quality System Engineer

Company

Boston Scientific

Location

George Town, Penang

Posted

June 14, 2026

Position Overview

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 corrective actions to impro...

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