Senior Quality System Engineer

Boston Scientific

📍 George Town, Penang, Malaysia 💼 Full-time 🕒 Posted June 06, 2026

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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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Job Details

Location George Town, Penang
Job Type Full-time
Category Engineers
Posted Date June 06, 2026
Application Deadline July 16, 2026