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Senior Quality System Engineer

Boston Scientific

George Town, Penang, Malaysia Full-time July 09, 2026
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Found Description

Key Responsibilities

  • Implementation of internal requirements and external laws, regulations, guidances and standards as applicable to Boston Scientific quality systems.

  • Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO, cGMP and MDR).

  • Lead and support site External Inspections.

  • Plan, coordinate and conduct scheduled audits to assess compliance with FDA, ISO, cGMP and MDR, other applicable standard requirements and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.

  • Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule.

  • Attend global conference calls and meetings related to the internal audit process and etc.

  • Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed i...

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    Found Details

    LocationGeorge Town, Penang
    CountryMalaysia
    TypeFull-time
    CategoryEngineers
    PostedJuly 09, 2026

    About Boston Scientific

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    Boston Scientific

    George Town, Malaysia

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