About the Role
We are seeking a motivated and detail-oriented Quality Engineer to join Cytek Biosciences. In this role, you will support Manufacturing, Supply Chain, and Customer-Facing functions to ensure product quality, compliance, and continuous improvement across the product lifecycle.
Key Responsibilities
- Conduct investigations and analysis of failed system modules prepare reports and recommend corrective actions for continuous quality improvement
- Support development and evaluation of test methods, protocols, and reports to meet regulatory and quality requirements
- Apply statistical methods with appropriate risk-based justification
- Contribute to design and manufacturing documentation (material specifications, drawings, inspection procedures, manufacturing processes)
- Drive continuous improvement in design control activities and quality tools usage
- Define critical-to-quality (CTQ) characteristics and inspection plans for components and finished devices
- Identify, analyze, and propose solutions for existing and potential quality issues
- Ensure product changes comply with regulatory and quality standards
- Stay updated on global quality standards and trends in life sciences and medical devices
- Provide risk management support across quality systems
- Perform other duties as assigned
Requirements & Qualifications
- Bachelor's Degree in Engineering or a related Scientific discipline
- Minimum 3 years of experience in Medical Device and/or Life Sciences industry
- Experience in life sciences instrument manufacturing
- Strong knowledge of product risk analysis and lifecycle management
- Familiarity with injection molding and assembly processes (preferred)
- Knowledge of reliability analysis, test methods, and validation
- Understanding of process validation (IQ, OQ, PQ)
- Working knowledge of:21 CFR Part 820 (Quality System Regulation)ISO 13485 (Quality Management Systems)ISO 14971 (Risk Management)
- Experience with CAPA, statistical sampling, FMEA, DOE, and quality risk management
- Strong problem-solving, analytical, and critical thinking skills
- Ability to collaborate and influence stakeholders across functions
- CQE certification is a plus
- Experience with regulatory audits and interaction with notified bodies is advantageous
Interested applicants are invited to click Apply Now or submit updated resume to [Confidential Information].
Please note that only shortlisted candidates will be contacted.
Rapid Recruitment Asia Pte Ltd (EA License No.: 16C8261)
Loh Yi Zhen (EA Registration No.: R1106592)
