SUMMARY

Responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. 

 

ESSENTIAL DUTIES & RESPONSIBILITIES Ensure the Quality System regulations are understood by all applicable company personnel and is functioning and effective at all times. Draft, review, maintain, distribute and train personnel on facility documentation and procedures, such as the Quality Manual and Quality System Procedures. Ensure compliance with Document Control, Device History Records and Management. Maintain Quality System Manual Standard Operating Procedures (QSM SOPs),  and Documentation Control. Prepare documentation and systems for compliance with the FDA requirements. Conduct and participate directly in quality inspections, internal and external audits, and FDA inspections. Participate in CAPA systems. Prepare reports and corrective actions. Maintain and update the Quality Manual, QA Procedures, and introduce Quality Plan improvements as applicable. Assist in analyzing and evaluating information concerning manufacturing problems, customer complaints, non-conformances, quality system, etc. Trend customer complaints and/or non-conformances. Assist and/or perform training activities in QM system processes and product quality. Confer with Operations about quality assurance and regulatory issues of products to ensure compliance with quality system. Maintain regular and punctual attendance. Perform other duties as assigned.

 

SUPERVISORY RESPONSIBILITIES

May provide technical guidance and/or supervision to personnel.