Quality Systems Engineer

Description

Job Summary: Quality Engineer to ensure regulatory compliance, investigate deviations, and improve processes in medical device production lines. Key Highlights: 1. Quality support for catheter production lines. 2. Investigation of NCRs and deviations using root cause analysis methodologies. 3. Collaboration with Manufacturing, Engineering, and Quality teams. Description and details of responsibilities * Provide quality support to production lines and catheter assembly processes * Ensure compliance with GMP, GDP, and ISO 13485 requirements * Investigate NCRs, process deviations, and manufacturing failures * Lead root cause analysis activities using 8D, 5 Why’s, Fishbone, and CAPA methodologies * Monitor quality KPIs, scrap trends, and rework performance * Support process validations, engineering changes, and continuous improvement initiatives * Participate in internal, corporate, and regulatory audits * Collaborate with Manufacturing, Process Engineering, Validation, and Quality teams Experience and Requirements * Bachelor’s degree in Engineering or related field * 2–3 years of experience as a Quality Engineer within the medical device industry * Experience in catheter manufacturing or medical device assembly operations * Knowledge of ISO 13485, FDA 21 CFR Part 820, and document control systems * Hands\-on experience supporting high\-volume production floor operations * Intermediate to advanced English level Benefits * Benefits according to the Federal Labor Law (LFT) * Life insurance * Transportation * Uniform * Guaranteed profit sharing * Savings fund * On-site medical services * Cafeteria * Life insurance * Savings fund * Cafeteria * Transportation * Uniform * Gym * Medical expense insurance **Number of vacancies** 1 **Department** Quality **Employment type** Permanent **Work modality** On-site **Shift** Day **Working hours** Full-time **Education** Bachelor’s degree with professional title **English** Speaking: Advanced, Writing: Advanced **Willingness to travel** No