Conduct internal audits according to ISO 9001:2008, ISO 13485:2003, 21 CFR Part 820 QSR of different departments and prepare reports and share with HOD.
• To facilitate HOD for developing and maintaining a Quality Management System (QMS) under ISO 9001:2008, ISO 13485:2003, 21 CFR Part 820 QSR, and other similar standards.
• Investigate Customer Complaints by using QC tools and carry out corrective actions with the help of the concerned department.
• Facilitate and take part in external audits of QMS by the third party and customers.
• Provide training to supervisors and workers regarding implementation of work instructions and check sheets.
• Manage the record of all Master documents issued by Quality Assurance departments.
• Secured calibration of instruments to be used on the production floor.
• To actively follow-up QA & RA department update QMS in view of the customer complaints, process non-conformances, internal audits, external audits, etc.
• Develop quality reports as required by HOD and management.