QC Staff

Responsibilities

• Develop and maintain documentation to ensure compliance with ISO 13485 and GMP standards
• Prepare and submit documents for the Medical Device Establishment License
• Create and update QC process control documentation and product specifications
• Establish laboratory testing methods including bacterial and fungal testing protocols
• Define QC machine calibration procedures and ensure implementation
• Perform daily QC checks across production lines
• Conduct microbial testing (bacterial and fungal) for each production batch
• Execute monthly environmental monitoring including water quality testing (iron-water, tank water) and airborne microbial surveys in production areas
• Conduct product functionality and final inspections prior to release
• Inspect incoming raw materials to ensure compliance with specifications
• Oversee in-process QC inspections during manufacturing
• Prepare and review QC documentation including product inspection reports and raw material receiving inspection record

Qualifications

• Diploma or higher in Science or a related field
• Minimum 3 years of experience in bacterial and fungal testing within a manufacturing environment (medical device industry preferred)
• Knowledge of equipment validation and QMS documentation
• Proficient in laboratory instruments and root cause analysis techniques