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Senior Quality System Engineer

🏢
Boston Scientific
📍 George Town, Malaysia
📍
Location George Town
📅
Posted June 06, 2026
🚗
Commute Local Area
🎯
Local Opportunity Near You!

This job is in your area. Enjoy a short commute and work close to home.

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Job Description

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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    📍 Location Details

    🌆
    City
    George Town
    🗺️
    Country
    Malaysia
    🚗
    Commute
    Local Area

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