jobs in Boston Scientific

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

Undisclosed

George Town, Pulau Pinang

Kongsi
Simpan

Lokasi Kerja

  • Penang George Town Pulau Pinang Malaysia

Penerangan Kerja

Tanggungjawab

Key Responsibilities:

  • Support implementation of internal quality system requirements and external regulatory standards (e.g., FDA, ISO 13485, cGMP, EU MDR)
  • Drive improvements to procedures and standards to enhance efficiency while maintaining compliance
  • Support and coordinate CAPA and compliance programs, including facilitating CAPA activities across functions
  • Participate in CAPA management activities and global quality system discussions
  • Conduct internal audits to identify gaps, ensure compliance, and drive continuous improvement
  • Support audit readiness, including front-room and back-room activities during external audits and inspections
  • Deliver quality system training and guidance to employees across the site
  • Lead or participate in system and process improvement initiatives using structured problem-solving approaches
  • Identify areas of non-compliance and recommend corrective actions to improve overall quality system effectiveness
  • Provide quality support and oversight for compliance investigations (e.g., non-conformance, OOS/OOT), where applicable

Requirements:

  • Bachelor’s Degree in Science, Engineering, or a related field
  • 2–5 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

About Us

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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