Senior Medical Device Quality Assurance Manager

5 days ago


Singapore beBeeQualityManagement Full time $90,000 - $120,000
Job Summary:

This role is responsible for leading the development and implementation of quality management systems in the medical device industry. The Senior Quality Management Specialist will oversee post-market surveillance activities, manage computer system validation, and ensure compliance with regulatory standards.

Key Responsibilities:
  • Develop and implement quality management strategies to enhance company efficiency and effectiveness.
  • Manage post-market surveillance activities, including recall and CSV processes, to ensure compliance with regulatory standards.
  • Lead computer system validation activities, including authoring and executing specifications and validation documentation.
  • Mentor affiliates in their validation activities to ensure compliance with related regulations and procedures.

Requirements:
  • Bachelor's degree in engineering or science.
  • 5 years of quality management experience in the medical device industry.
  • 3 years of CSV documentation and processes validation.
  • Lead auditor certification to ISO 13485:2016, ISO 9001:2015, and ISO 27001.
  • Well-versed in QMS and SDLC, ERP, and computer systems used in the medical industry.

Benefits:

No specific information available.


Others:

Only shortlisted candidates will be notified. Please read our privacy statement on our corporate website.



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