Senior Engineer

4 weeks ago


Singapore EA RECRUITMENT PTE. LTD. Full time
Job Summary

EA RECRUITMENT PTE. LTD. is seeking a highly skilled Senior Engineer - Quality Assurance to join our team. The ideal candidate will have a strong background in quality assurance, with experience in medical devices and a proven track record of driving process improvements.

This is a challenging role that requires a high level of technical expertise, excellent communication skills, and the ability to work effectively in a dynamic environment.

  • Conduct supplier qualification and performance assessments, ensuring that our suppliers meet the highest quality standards.
  • Lead the investigation and resolution of quality issues, working closely with internal and external stakeholders to identify root causes and implement corrective actions.
  • Collect, analyze, and respond to customer feedback and complaints, ensuring that our products meet customer needs and expectations.
  • Support internal and external audits, ensuring that our quality management systems are robust and effective.
  • Evaluate and verify new parts and samples, ensuring that they meet our quality standards.
  • Establish and maintain inspection criteria for incoming, in-process, and final products.
  • Identify quality issues, develop and implement corrective actions, and drive continuous improvement initiatives.
  • Authorize the release of products, reviewing and approving certificates of conformity and certificates of analysis.
  • Perform monthly data analysis on product quality and quality objectives, identifying trends and areas for improvement.
  • Review and approve documentation, including design history records.
  • Participate in new projects, providing quality management and control expertise.

Requirements

  • Possess a minimum Diploma/Degree in a relevant subject area, with at least 3 years' experience in medical device quality assurance and/or regulatory affairs.
  • Hold an ISO 13485:2016 certification internal auditor, with a strong understanding of quality control tools.

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