Senior Quality Assurance Specialist

3 days ago


Singapore BIOBOT SURGICAL PTE. LTD. Full time
Senior QA Engineer

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

Key Responsibilities:
  • Develop and implement Quality Management Systems (QMS) to ensure compliance with regulatory requirements such as ISO 13485, MDD 93/42/EEC, and FDA 21 CFR 820.
  • Conduct internal and external audits to ensure QMS effectiveness and identify areas for improvement.
  • Manage document control, including the development and maintenance of quality procedures and SOPs.
  • Collaborate with cross-functional teams to ensure the execution and effectiveness of key quality system processes.
  • Investigate and resolve non-conformities, including product and process deviations.
  • Manage customer complaints and track complaint closure.
  • Update Device Master Records (DMRs) and QMS documents.
Requirements:
  • Bachelor of Engineering or equivalent.
  • 10 years' experience in Quality Assurance.
  • 5 years' experience in QMS, including MDR, EN ISO 13485, and FDA 21 CFR 820.
  • Certified ISO 13485 Lead Assessor.

Please attach your complete CV to your application.

We are looking for a skilled and experienced QA Engineer to join our team. If you have a strong background in quality management and regulatory compliance, we encourage you to apply.



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