Responsibilities

• Manage and ensure compliance with the Quality Management System under applicable standards such as ISO 9001, ISO 13485, and customer-specific requirements.
• Ensure compliance with regulations applicable to medical and electronic products.
• Lead internal, external, customer, and regulatory audits.
• Develop and implement continuous improvement strategies focused on reducing defects, rework, and cost of poor quality.
• Supervise Incoming Quality, IQC, IPQC, OQC, SQE, Document Control, and Supplier Quality areas.
• Monitor and track quality key performance indicators (KPIs).
• Coordinate root cause analysis and corrective/preventive actions using tools such as 8D, CAPA, Fishbone, 5 Why’s, and FMEA.
• Ensure proper validation and control of electronic manufacturing and special processes.
• Participate in New Product Introduction (NPI) transfers and engineering changes.
• Ensure training an...