Quality System Engineer

Boston Scientific

George Town, Penang, Malaysia Full-time June 19, 2026

Found 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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