Quality Analyst

Description

Job Summary: Join Labtest's Quality Management team as a Quality Analyst and contribute to excellence in maintaining and enhancing the Quality Management System. Key Highlights: 1. Essential role in regulatory compliance and continuous improvement of the QMS. 2. Fundamental support in quality-related processes, projects, and initiatives. 3. Active collaboration in data analysis, audits, and training. Join Labtest's Quality Management team! We have an opening for a Quality Management Analyst! Commitment, respect, excellence, results orientation, dynamism, courtesy, effective communication, customer focus, and teamwork are highly valued qualities for our team. If this profile resonates with you, apply to our position! **Responsibilities and Duties** * Interpret regulations, identify existing gaps in the Quality Management System, assess risks, propose improvements, plan and implement adjustments, ensuring compliance with applicable/current regulatory and normative requirements and their updates. * Support company departments in identifying and mapping business-critical processes, defining interfaces, establishing controls and monitoring mechanisms, and proposing changes and improvements. * Support management in developing, planning, implementing, maintaining, and enhancing quality-related projects, programs, and initiatives aimed at increasing multi-functional teams' knowledge of and adherence to quality requirements and the Quality Policy across all business areas and organizational levels. * Develop, critically review, and approve quality system documentation, ensuring its adequacy relative to reference standards, sanitary legislation, and business needs. * Support the handling of product, process, and system nonconformities, as well as complaints, through registration, critical analysis, and follow-up of proposed corrective actions. * Participate in and facilitate root cause analysis meetings for nonconformities and develop corrective and preventive action plans, supporting departments in identifying causes and proposing actions, and monitoring implementation and effectiveness of such actions. * Analyze nonconformity data to identify trends. * Collaborate in developing and delivering training on the QMS and Good Manufacturing Practices (GMP). * Evaluate the conformity of the Quality Management System through planning, conducting, and assessing the results of internal and external audits. * Support Quality Management in preparing Management Review Meetings by collecting and analyzing quality system-related data, and proposing recommendations and improvements. * Support other Quality functions in critically reviewing proposed changes to products and processes, and in planning, communicating, implementing, monitoring, and evaluating the effectiveness of implemented changes. * Participate in planning and executing company projects as assigned, and interact with project teams to provide necessary guidance, ensuring compliance with Project Management processes and any other Quality System or regulatory requirements. * Support other departments involved in managing failures reported via product complaints and related returns. * Support the Quality team and other company departments regarding the Risk Management process. **Requirements and Qualifications** * Bachelor’s degree in Production Engineering, Pharmacy, Biomedicine, or related fields; * Intermediate English proficiency preferred; * Advanced proficiency in Microsoft Office suite; * Familiarity with Google tools and Canva; * Knowledge of ISO 9001 and/or ISO 13485 standards and Good Manufacturing Practices (GMP) for health products — RDC 665/2022; * Familiarity with data analysis and problem-solving tools (e.g., Ishikawa Diagram, 5 Whys), applied to nonconformity evaluation; * Experience conducting audits (internal and external); * Prior experience in developing and reviewing QMS documentation. **Additional Information** * Employment Type: CLT; * Willingness to work in Lagoa Santa; * Work Model: On-site — 8:00 AM to 5:40 PM (Monday to Friday). * Benefits: * Flexible Benefit Card; * Health Insurance; * Dental Insurance; * Life Insurance; * Transportation Allowance; * Charter Bus Service (available in certain regions); * On-site Cafeteria. Founded in 1971, Labtest Diagnóstica S.A. is one of Brazil’s largest in vitro diagnostic manufacturers, nationally and internationally recognized as a biotechnology market leader. Marking its 50th anniversary, the Labtest Group was acquired by VIRTUE DIAGNOSTICS, an innovative IVD company headquartered in Singapore, bringing a youthful perspective and bold impetus to research and development. Its mission—to provide life-enhancing solutions—now aligns with the purpose of accelerating diagnostic innovations for a healthier world. Labtest and Virtue are united to deliver the best reagent and equipment solutions for clinical diagnostics to the Brazilian and Latin American markets. We are Labtest. We are Virtue.