Quality Manager

Job Description

• Establishing, implementing, and maintaining comprehensive quality management systems in compliance with regulatory standards such as ISO 13485, FDA QSR (Quality System Regulation), and other relevant regulations.
• Creating and updating standard operating procedures (SOPs) for quality processes across the organization.
• Ensuring compliance with applicable regulatory requirements, including FDA regulations, CE marking requirements, and other international standards.
• Liaising with regulatory agencies and notified bodies during audits and inspections.
• Conducting risk assessments and implementing risk management processes to identify and mitigate potential hazards associated with medical products.
• Overseeing the design, implementation, and effectiveness of quality control activities, including inspection, testing, and validation procedures.
• Establishing and maintaining supplier quality agreements and monitoring supplier performance to ensure the consistency and reliability of incoming materials and components.
• Leading investigations into product non-conformances, customer complaints, and adverse events to identify root causes and implement corrective and preventive actions (CAPAs).
• Implementing processes for product traceability and recall management as necessary.
• Providing training to employees on quality procedures, regulations, and best practices.
• Maintaining documentation related to quality management activities, including quality records, validation reports, and regulatory submissions.
• Driving continuous improvement initiatives to enhance quality processes, reduce defects, and optimize operational efficiency.
• Implementing tools and methodologies such as Lean Six Sigma to identify and eliminate waste and variation in processes.
• Collaborating with cross-functional teams including R&D, manufacturing, engineering, and marketing to ensure quality requirements are met throughout the product lifecycle.
• Serving as a quality representative in cross-functional project teams and decision-making forums.
• Conducting internal audits to assess compliance with quality management systems and regulatory requirements.
• Coordinating external audits and inspections by regulatory agencies and notified bodies, and managing responses to audit findings.
• Establishing key performance indicators (KPIs) and quality metrics to monitor the effectiveness of quality management systems.
• Generating periodic reports and presenting quality performance data to senior management for review and decision-making.