Quality Assurance Engineer

Description

Position Summary: Quality Engineer responsible for monitoring, analyzing, and investigating customer complaints and product defects, implementing quality tools, and leading continuous improvement initiatives. Key Highlights: 1. Leads investigations of product and process failures 2. Implements quality procedures and tools 3. Ensures compliance with product specifications Description and details of responsibilities * Monitors, collects, and analyzes customer complaints by product family. * Monitors, collects, and analyzes defects and rejections found in-process by product family. * Investigates and documents quality system and continuous improvement metrics. * Controls and manages temporary deviations (TDs) impacting the business unit or product family. * Monitors, controls, and ensures disposition of nonconforming material. * Implements quality procedures, methodologies, and tools to meet product and process specifications. * Analyzes and leads investigations into product and process failures—including supplier-related issues—and validates the effectiveness of corrective actions. * Supports validation processes and protocols in collaboration with the Engineering Department, and is responsible for generating test method validations. * Develops and tracks guidelines for product and component test methods. * Ensures generation of analytical and/or statistical information for the department, collaborating with the Engineering Department to establish, control, and improve process effectiveness. * Supports required quality activities to ensure the Quality System remains active and up-to-date. Experience and Requirements 5 years of experience as a Quality Engineer in assembly processes, preferably in the medical device and high-volume manufacturing industries. English language proficiency. Industrial, Chemical, Electronic, Mechanical Engineering, or related degree. 1\. Handling of finished goods and raw materials. 2\. Measurement Systems Analysis (MSA). 3\. Quality systems (NOM-241, ISO 13485-2016 MDSAP, FDA-QSRs, EU MDR, CANADA): 4\. CAPA/SCAR management. 5\. Supplier and raw material control. 6\. Experience leading teams in root cause analysis, preventive and corrective actions. 6\. Validation of manufacturing processes, equipment, and critical advanced test methods (VP, TP, CPLN, QP). 7\. Advanced statistical tools: 8\. Design of Experiments. 9\. ANOVA. 10\. Probability analysis. 11\. Process and product risk analysis. 12\. Decision-making, investigation, and validation tools (HA). 13\. Continuous improvement tools (Lean Manufacturing / Six Sigma). Benefits * Benefits according to the Federal Labor Law (LFT) * Life insurance * Savings fund * Medical expense insurance * Transportation * Indexation plan * On-site medical services * Cafeteria * Savings fund * Transportation **Number of vacancies** 1 **Department** Quality **Employment type** Permanent **Work modality** Hybrid **Shift** Day **Working hours** Full-time **Education** Professional degree **English** Spoken: Advanced, Written: Advanced **Willingness to travel** No