QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking a Quality Engineer to ensure the quality and regulatory compliance of medical devices during the manufacturing process. The ideal candidate should have experience in quality assurance and a solid understanding of regulatory standards, particularly in the medical device or pharmaceutical industry
Job Summary
The Quality Engineer ensures regulatory compliance of medical devices throughout the manufacturing process.
This role involves developing quality assurance strategies, overseeing production processes, and managing product quality.
The position requires supporting new product transfers and validating processes including IQ, OQ, and PQ.
Matching Summary
Match Score: 85
QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking a Quality Engineer to ensure the quality and regulatory compliance of medical devices during the manufacturing process. The ideal candidate should have experience in quality assurance and a solid understanding of regulatory standards, particularly in the medical device or pharmaceutical industry.
Skills & Requirements
Must-have
FDA and ISO 13485 regulatory compliance
Root cause analysis and corrective actions
Process validation IQ OQ PQ execution
New product introduction quality support
Internal and external audit management
Nice-to-have
Cross-functional team collaboration skills
Cost improvement project leadership
Customer complaint resolution experience
Continuous improvement culture promotion
Technical training and development abilities
Key Requirements
Degree in Engineering or Science with 2-5 years experience
Knowledge of FDA regulations and ISO 13485 standards