Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities, ensuring GMP and ISO13485 requirements are implemented correctly
Job Summary
Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities, ensuring GMP and ISO13485 requirements are implemented correctly.
Review NC reports for compliance, ensure proper NC/CAPA process is followed, and maintain the NC/CAPA log system for accuracy.
Independently manage DCC related work including document master list maintenance, record archiving, distribution & retrieval, and CM related work such as ECR scan & registration.
Matching Summary
Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities, ensuring GMP and ISO13485 requirements are implemented correctly.
Skills & Requirements
Must-have
Quality standards and procedures
GMP and ISO13485 compliance
NC/CAPA process management
Document control (DCC)
Change management (CM)
Nice-to-have
Excellent logical thinking
Effective interpersonal skills
Trouble-shooting skills
Good communication and training skills
Quick learner
Key Requirements
More than 5 years in Quality Assurance
Experience in GMP or ISO quality systems
College / B.S. in engineering or related discipline