Quality Analyst

Description

Job Summary: Quality Analyst to maintain and improve the Quality Management System in compliance with regulatory standards for medical/hospital devices. Key Highlights: 1. Implementation of maintenance and continuous improvement of the QMS (ISO 13485, RDC 665/2022). 2. Management of non-conformity handling (CAPA) and improvement plans. 3. Support for internal and external audits, as well as regulatory inspections. **Quality Analyst** A large-scale company is hiring a **Quality Analyst** to maintain and improve the Quality Management System, ensuring compliance with regulatory standards and applicable requirements for the medical device/hospital equipment sector. **Main Responsibilities:** * Maintain and continuously improve the Quality Management System (QMS), in accordance with **ISO 13485** and **RDC 665/2022**; * Draft, review, and control quality documents, including procedures, work instructions, and records; * Lead and monitor non-conformity handling, corrective and preventive actions (**CAPA / RACP**), and improvement plans; * Support internal and external audits, as well as regulatory inspections; * Analyze quality indicators and propose actions for continuous improvement; * Manage training related to quality processes; * Support post\-market processes, including complaints and technovigilance, where applicable. **Requirements:** * Completed undergraduate degree in **Engineering, Pharmacy, Biomedicine, or related fields**; * Experience with **Quality Management Systems**, preferably in medical device companies; * Knowledge of **ISO 13485**, **ANVISA** regulations, and **RDC 665/2022**; * Experience with CAPA, document control, and audits; * Intermediate/advanced Microsoft Office suite proficiency. **Preferred Qualifications:** * Prior experience with **ISO 13485 / RDC 665**; * Knowledge of ANVISA regulatory processes; * Intermediate English proficiency. **Benefits:** Competitive market-aligned benefits package. **Working Hours:** Monday to Friday, business hours. Minimum Education Level: Undergraduate Degree