Job Summary: Ensure the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in the medical device industry, coordinating internal and external audits. Key Highlights: 1. Experience in quality management systems within the medical device industry 2. Proficiency in eQMS systems and knowledge of ISO regulatory standards 3. Certification as an Internal Auditor (Lead Auditor) is desirable Job Description and Responsibilities **Job Objective** Ensure the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), guaranteeing compliance with applicable regulations in the medical device industry, as well as the proper execution of internal and external audits. **Key Responsibilities** * Coordinate and conduct internal and external quality system audits. * Ensure compliance with regulations and standards (ISO 9001, ISO 13485\). * Administer and monitor quality system processes within the eQMS. * Participate in the preparation and execution of Management Review. * Maintain direct communication with Customer Service to ensure compliance with customer requirements and specifications. * Manage audit findings and ensure effective closure of corrective actions. * Support continuous improvement initiatives for the quality system. Experience and Requirements **Education:** * Industrial Engineering or related field. **Experience:** * Minimum 1 year of experience in quality systems or similar roles. **Technical Knowledge:** * Proficiency in eQMS systems (e.g., TrackWise, ComplianceQuest, or similar). * Knowledge of ISO 9001 and ISO 13485\ standards. * Experience conducting internal and external audits. **Skills** * Critical and analytical thinking. * Effective communication. * Organization and time management. * Attention to detail. **Mandatory Requirements (Must)** * Knowledge of quality systems within the medical device industry. * Experience in internal and external audits. * Certification as an Internal Auditor (Lead Auditor). * Experience in preparing and conducting Management Review. * Interaction with internal/external customers to ensure compliance with quality requirements. **Desirable (Nice to have)** * Lead Auditor certification. **Languages** * Advanced English (ability to participate in meetings and professional communication). Benefits * Benefits in accordance with the Federal Labor Law (LFT) * Life insurance * Savings fund * Medical expense insurance * Transportation allowance * Guaranteed profit-sharing * On-site medical services * Cafeteria * Life insurance * Annual bonuses * Savings fund * Medical expense insurance **Number of Openings** 1 **Department** Quality **Employment Type** Permanent **Work Mode** On-site **Shift** Day shift **Working Hours** Full-time **Education Requirement** Bachelor's degree with professional title **English Proficiency** Spoken: Intermediate, Written: Intermediate **Willingness to Travel** No
Juan García
Indeed · HR
Juan García
Indeed · HR
