Sr. Engineer, Quality Engineering

QUASAR MEDICAL (SINGAPORE) PTE. LTD.

Singapore
Not specified (assumed to be on-site based on the nature of the role).
Fda regulatory compliance knowledge
Iso 13485 standards implementation
Root cause analysis and capa
Quasar Medical (Singapore) Pte. Ltd. is seeking a Sr. Engineer in Quality Engineering to ensure the quality and regulatory compliance of medical devices during manufacturing. The role involves developing quality assurance strategies, managing production quality, and supporting product transfers, with a focus on adherence to industry standards

Job Summary

  • The role ensures quality and regulatory compliance of medical devices throughout the manufacturing process.
  • Responsibilities include developing quality assurance plans, supporting audits, and managing product-related deviations.
  • The position requires leading root cause analysis and driving corrective actions to resolve non-conformities.

Matching Summary

Match Score: 85

Quasar Medical (Singapore) Pte. Ltd. is seeking a Sr. Engineer in Quality Engineering to ensure the quality and regulatory compliance of medical devices during manufacturing. The role involves developing quality assurance strategies, managing production quality, and supporting product transfers, with a focus on adherence to industry standards.

Skills & Requirements

Must-have

  • FDA regulatory compliance knowledge
  • ISO 13485 standards implementation
  • Root cause analysis and CAPA
  • Process validation IQ OQ PQ
  • New product transfer support

Nice-to-have

  • Cross-functional team collaboration
  • Continuous improvement culture
  • Customer complaint resolution skills
  • Cost improvement project leadership

Key Requirements

  • Degree in Engineering or Science
  • 2-5 years progressive Quality responsibility
  • Experience in medical device manufacturing
  • Strong analytical and problem-solving skills

Work Rights

Not specified

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