Quality Manager (Medical Processes Exp- Parq. Ind. El Bajio)

PRIMARY OBJECTIVES AND RESPONSIBILITIES

• Lead daily quality operations at the manufacturing site, including incoming, in-process, and final inspection, testing, and product release.
• Oversee Quality Management System (QMS) processes such as change control (ECR/ECO), document management, records retention, training/competency, CAPA, NCMR, complaints, and calibration.
• Supervise and develop Quality Engineers and Quality Assurance personnel, including performance management, coaching, and workforce planning.
• Ensure compliance with FDA QMSR, ISO 13485, MDSAP, and Good Documentation Practices through effective procedures and controls.
• Lead internal and external audits, including ISO/MDSAP audits and regulatory inspections, serving as the site's primary host.
• Maintain and monitor quality metrics and KPIs, presenting monthly results and driving actions through Management Review and other Quality governance processes.
• Lead investigations for quality trends and issues, implementing corrective and preventive actions to improve outcomes.
• Support risk management processes and ensure integration into key quality activities, including complaints, nonconformances, and change control.