Responsibilities

• Maintain the Quality Management System in alignment with established documentation and approved procedures.
• Oversee the daily functions and training of quality inspectors.
• Ensure product compliance with documented procedures, including managing and generating Non-Conformance Material Reports (NCMRs).
• Supervise quality inspections of received materials and oversee material receiving processes.
• Conduct production area audits to verify conformance with documented procedures and the Quality Management System, coordinating with production supervisors. Support supervisors in identifying corrective actions without directly providing solutions, empowering them to take ownership.
• Notify the RA/QA Manager of any deviations from documented procedures that could pose risks to product quality.
• Manage documentation control related to procedural documents, including handling SCN/ECN updates and ensuring proper filing and retention of Device History Records (DHRs).
• Foster professional, respectful, and constructive communication with team members to encourage collaboration and support corrective actions.
• Maintain open and proactive communication with your manager to report conditions or concerns that could impact the product, other areas, or customer satisfaction.