Quality Assurance Manager

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 Operatio