QUALITY ENGINEER - CUSTOMERS

Description

Job Summary: Quality Engineer focused on customers and systems, responsible for regulatory compliance, audits, and complaint management for medical devices. Key Highlights: 1. Focus on customer management and quality systems. 2. Experience with medical devices and automotive requirements. 3. Leadership in internal, external, and DDR audits. ##### **Job Opportunity** QUALITY ENGINEER\- CUSTOMERS ##### **Region** Monte Mor, Hortolândia, Indaiatuba ##### **Description** Professional Profile – Customer and Systems Quality Engineer (Medical Focus) A Quality Engineering professional with strong expertise in customer management, audits, and quality systems, experienced in medical devices and interface with automotive industry requirements. Responsible for ensuring regulatory compliance, conducting audits, and leading customer complaint management to ensure continuous improvement and product safety. Education and Knowledge Bachelor's degree in Engineering (Industrial, Chemical, Biomedical, Mechanical, or related fields). Experience with quality management systems for medical devices. Knowledge of standards and regulatory requirements such as: ISO 13485 – Quality management system for medical devices IATF 16949 – Automotive quality management system Experience with regulatory processes and traceability of medical products. Technical English for communication with customers and audits. Technical Competencies Customer complaint and quality event management and resolution. Conducting DDR – Device Deficiency Reports, analysis and investigation of failures related to medical devices. Interface with regulatory departments for evaluation of adverse events and product deviations. Leadership in internal, external, and DDA audits.