Quality Engineer

Cytek Biosciences

Singapore
Not specified
Bachelor's degree in engineering or related scientific discipline
Minimum 3 years experience in medical device industry
Knowledge of 21 cfr part 820 iso 13485 iso 14971
Cytek Biosciences is seeking a detail-oriented Quality Engineer in Singapore to support product quality and compliance across various functions. The ideal candidate will have a background in the Medical Device or Life Sciences industry, with a strong focus on quality management practices

Job Summary

  • This role supports Manufacturing, Supply Chain, and Customer-Facing functions to ensure product quality and compliance across the product lifecycle.
  • The candidate will conduct investigations of failed system modules, apply statistical methods for risk-based justification, and drive continuous improvement in design control activities.
  • Key responsibilities include defining critical-to-quality characteristics, ensuring product changes comply with regulatory standards, and providing risk management support across quality systems.

Matching Summary

Match Score: 85

Cytek Biosciences is seeking a detail-oriented Quality Engineer in Singapore to support product quality and compliance across various functions. The ideal candidate will have a background in the Medical Device or Life Sciences industry, with a strong focus on quality management practices.

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering or related Scientific discipline
  • Minimum 3 years experience in Medical Device industry
  • Knowledge of 21 CFR Part 820 ISO 13485 ISO 14971
  • Experience with CAPA statistical sampling FMEA DOE
  • Understanding of process validation IQ OQ PQ

Nice-to-have

  • CQE certification is a plus
  • Experience with regulatory audits interaction with notified bodies
  • Familiarity with injection molding and assembly processes
  • Strong problem-solving analytical and critical thinking skills
  • Ability to collaborate and influence stakeholders across functions

Key Requirements

  • Bachelor's Degree in Engineering or related Scientific discipline
  • Minimum 3 years of experience in Medical Device and/or Life Sciences industry
  • Working knowledge of 21 CFR Part 820 ISO 13485 ISO 14971
  • Experience with CAPA statistical sampling FMEA DOE and quality risk management
  • Understanding of process validation (IQ, OQ, PQ)

Work Rights

Not specified

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