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Kerja Sepenuh Masa, Senior Quality System Engineer di Boston Scientific Pulau Pinang - Maukerja

Senior Quality System Engineer

Boston Scientific

Undisclosed

Sepenuh Masa

George Town, Pulau Pinang

Kongsi
Simpan

Lokasi Kerja

  • Penang George Town Pulau Pinang Malaysia

Penerangan Kerja

Tanggungjawab

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 guidance to teams on quality system requirements
  • Gather and analyze quality system data to support management review and decision making
  • Participate in global quality system initiatives and discussions
  • Provide quality oversight to analytical laboratory activities, including compliance with cGMP and support for investigations (e.g., OOS/OOT), where applicable
Requirements:
  • Bachelor’s Degree in Science, Engineering, or a related field
  • Minimum 9 years of experience in a manufacturing environment
  • Experience in the medical device industry is desirable
  • Experience in: Non-conformance and CAPA management, Management Review processes, Internal and external audits
Required Skills & Knowledge:
  • Knowledge of ISO 13485, EU MDR, and FDA regulations
  • Knowledge of cGMP and combination product/device regulations
  • Lead Auditor certification is an added advantage
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