QA Specialist

Description

Job Summary: We are seeking a Quality Specialist with experience in medical devices or in vitro diagnostics, focused on maintaining and improving the Quality Management System. Key Responsibilities: 1. Lead investigations of nonconformities and track CAPAs. 2. Coordinate internal audit activities and support external audits. 3. Administer and maintain the Quality Management System. **Job Description:** We are seeking a Quality Specialist with experience in the medical device or in vitro diagnostic (IVD) industry, focused on maintaining and improving the Quality Management System, tracking CAPAs, handling nonconformities, conducting audits, and ensuring compliance with ISO 13485 standards. Candidates with experience as a Technical Director—bringing knowledge of local regulatory requirements and quality best practices applicable to the sector—are especially valued. **Academic Qualifications** * Bachelor’s degree in Bacteriology, Microbiology, Chemistry, Pharmaceutical Chemistry, or related fields. * Advanced training or specialization in quality management systems, auditing, or medical devices is desirable. * Intermediate to advanced English proficiency **Required Experience** * Minimum 2 years of experience in Quality roles within companies manufacturing: medical devices, in vitro diagnostics (IVD), clinical laboratories, or pharmaceutical/healthcare industries. **Demonstrable Experience** * Nonconformity management. * CAPAs (Corrective and Preventive Actions). * Document management. * Change control. * Risk management. * Internal and external audits. * Maintenance of Quality Management Systems. **Technical Knowledge** * Quality Management System compliant with ISO 13485 (mandatory). * Knowledge of ISO 9001:2015 is desirable. * Quality indicator management. * Handling of controlled documentation. * Deviation investigation and root cause analysis. **Main Responsibilities** * Administer and maintain the Quality Management System. * Lead investigations of nonconformities and track CAPAs. * Coordinate internal audit activities and support external audits. * Ensure document control for procedures, records, and forms. * Monitor quality plans, training, and continuous improvement initiatives. * Manage quality indicators and reports. * Participate in process improvement and regulatory compliance projects. * Provide technical and documentation support to internal and external customers. **Location****Employment Type****Work Model** Bogotá D.C., DC, CO Full-time CLT Hybrid