Quality Management System (QMS) and Regulatory ComplianceDevelop, implement, maintain, and continuously improve the company's Quality Management System.Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485:2016, MDSAP and applicable regulatory requirements.Establish and maintain quality policies, procedures, work instructions, and documentation.Oversee document control, records management, and change control processes.Monitor quality performance metrics and identify opportunities for improvement.Monitor regulatory changes and assess their impact on company operations.Support regulatory submissions, registrations, and customer or regulatory inquiries as applicable.Maintain appropriate regulatory documentation and records.Audits & Corrective ActionsPlan and oversee internal, external, customer, and regulatory audits.Serve as the primary contact for quality-related customer and regulatory audits.Lead investigations, nonconformance reviews, root cause analysis, and corrective and preventive actions (CAPA).Ensure timely and effective resolution of audit findings and quality issues.Verify effectiveness of corrective actions.Manufacturing Quality & Continuous ImprovementOversee incoming, in-process, and final inspection activities.Work with manufacturing and engineering to resolve quality issues and improve production processes.Review and analyze scrap, rework, customer complaints, and other quality performance indicators.Lead initiatives to reduce defects, improve product reliability, and prevent recurrence of quality issues.Support validation and qualification activities, including equipment, processes, and production methods.Ensure appropriate controls are in place for suppliers and outsourced processes.Leadership & CollaborationProvide leadership, direction, and development for quality personnel.Establish departmental goals and performance expectations.Collaborate with cross-functional teams to ensure quality is integrated throughout the manufacturing process.Promote employee awareness and accountability for quality and regulatory compliance.Provide quality-related training and guidance throughout the organization.
