Job Summary: Responsible for maintaining the effectiveness of the quality management system and all quality aspects within a GMP and ISO 13485 environment. Key Responsibilities: 1. Maintain the effectiveness of the quality management system. 2. Participate in the review of manufacturing and testing of new products. 3. Support the development of new products and execute validation protocols. Description and Details of Activities * Responsible for maintaining the effectiveness of the quality management system and all quality aspects, including first-article inspections * Capability studies, DOE * Development of procedures * Root cause analysis * Corrective and preventive actions and all other areas of quality control programs within a GMP and ISO 13485 environment Experience and Requirements * Participate in the review of manufacturing and testing of new products to ensure compliance with quality requirements. * Maintain procedures aligned with current practices and regulations. * Interface with customers, suppliers, and external consultants as needed. * Ensure proper use and calibration of measuring devices, calipers, micrometers. * Track all non-conformance reports, MRB issues, and parts. * Coordinate timely analysis and closure of CAPA/CAR. * PPAD documentation * Support new product development, develop and execute process validation protocols. * Act as liaison between the company and the customer. * Develop and implement performance improvement ideas and tools/reports across all departments. Benefits * Benefits according to the Federal Labor Law (LFT) * 4% Savings Fund * Medical expense insurance, major medical, minor medical, vision, and dental * 3 days paid mental health leave * 15 days year-end SD (conditional) **Number of vacancies** 1 **Department** Quality **Contract type** Permanent **Work modality** On-site **Shift** Day shift **Working hours** Full-time **Schedule*** Monday to Thursday 7:30 am – 5:30 pm / Friday 7:30 am – 3:00 pm **Education** Bachelor’s degree with professional title **English** Spoken: Advanced, Written: Advanced **Willingness to travel** Yes