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Senior Quality Assurance Engineer

2 months ago

Singapore BIOBOT SURGICAL PTE. LTD. Full time
Job Description

BIOBOT SURGICAL PTE. LTD. is seeking a highly skilled Senior Quality Assurance Engineer to join our team.

Key Responsibilities:
  • Quality Management System (QMS) Compliance
    • Ensure all processes and activities are in compliance with ISO 13485, MDD 93/42/EEC, FDA 21 CFR 820, and other statutory requirements.
  • Document Control
    • Responsible for maintaining and updating quality documents, including the Quality Manual, Quality Procedures, and SOPs.
  • Audit and Compliance
    • Coordinate internal and external audits, including supplier audits.
    • Manage non-conformities and track progress of corrective actions.
  • Quality System Support
    • Provide quality system support to cross-functional teams.
    • Ensure the effective execution of key quality system processes.
  • Design Change Management
    • Track and manage design changes in a timely manner.
  • Customer Complaint Management
    • Manage customer complaints and track complaint closure.
  • Device Master Record (DMR) and QMS Document Updates
    • Update the DMR and QMS documents as required.
Requirements:
  • Education: Bachelor of Engineering or equivalent.
  • Experience: 10 years' experience in Quality Assurance, 5 years' experience in QMS, and certified ISO 13485 Lead Assessor.
  • Skills: Strong attention to detail, quality management, quality assurance, unit testing, ISO, test cases, assessor, C#, Appium, C++.