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Senior Quality System Engineer

Boston Scientific • George Town, Penang, Malaysia • Posted June 21, 2026

Location George Town, Penang
Job Type Full-time
Category Engineers
Posted June 21, 2026

Key Responsibilities:


  • Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)

  • Lead and support external inspections and regulatory audits

  • Plan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actions

  • Identify areas of non-compliance and drive continuous improvement initiatives

  • Act as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closure

  • Maintain and continuously improve site CAPA processes and systems

  • Develop, track, and report CAPA metrics to support management review activities

  • Support corrective and preventive action processes across the site

  • Collaborate cross-functionally to standardize quality system policies and procedures

  • Provide training and g...

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