Senior Product Quality Engineer

2 weeks ago


Singapore EA RECRUITMENT PTE. LTD. Full time
Job Summary

We are seeking a highly skilled Senior Product Quality Engineer to join our team at EA Recruitment Pte. Ltd. The ideal candidate will have a strong background in quality control and assurance, with experience in medical device manufacturing and ISO 13485 certification.

Key Responsibilities
  • Conduct thorough assessments and reviews of supplier qualifications, performance, and process capabilities to ensure compliance with quality standards.
  • Investigate and resolve quality issues, analyze root causes, and implement corrective actions to prevent recurrence.
  • Collect, handle, and follow up on customer feedback and complaints to ensure timely resolution and continuous improvement.
  • Support internal and external audits, including preparation, execution, and follow-up activities.
  • Evaluate, verify, and validate new parts and samples to ensure they meet quality standards.
  • Establish and maintain inspection criteria for incoming, in-process, and final products to ensure quality consistency.
  • Identify quality issues, non-conformities, and corrective actions, and drive continuous improvement initiatives.
  • Authorize the release of products, review and approve certificates of conformance, and ensure compliance with quality standards.
  • Analyze monthly data on product quality and quality objectives to identify trends and areas for improvement.
  • Review and approve documentation, including design history records.
  • Participate in new projects, commercial product quality management, and control initiatives.
  • Drive change management and control activities to ensure seamless implementation of quality improvements.
Requirements
  • Possess a minimum Diploma/Degree in a relevant subject area, with 3-5 years of experience in medical device QA and/or RA.
  • Hold ISO 13485:2016 certification as an internal auditor, which is highly advantageous.
  • Familiarity with quality control tools and methodologies.
What We Offer

Candidates who meet the requirements will be considered for this exciting opportunity to join our team at EA Recruitment Pte. Ltd. We offer a competitive salary, excellent welfare and benefits, and career progression opportunities.



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