Job Description and Responsibilities Responsible for monitoring quality guidelines and manufacturing procedures for the product, overseeing the product packaging process, product inspection, and product handling. Experience in technology transfers and validations Implement adjustments and modifications to production programs within established timeframes, ensuring variations resulting from such changes remain within permitted limits. Properly requisition documentation supporting the execution of production programs developed at the plant, as well as documentation for investigating recurring root causes of product defects. Responsible for tracking quality indicators, productivity, scrap rates, manufacturing of validation protocols for products, processes, machinery, and equipment, as well as for proper product transfer. Verify operation and calibration of equipment, systems, and controls within the cleanroom before, during, and after a transfer to ensure they operate within specified parameters and appropriate capacity. Experience and Requirements Minimum 3 years of experience in medical device manufacturing preferred. Experience managing product and process documentation for FDA and ISO procedures and work instructions. Experience integrating new products and processes. Experience with validation protocols. Experience validating products and equipment. Advanced knowledge of statistical process control. Benefits * Benefits according to the Federal Labor Law (LFT) **Number of openings** 1 **Department** Engineering **Employment type** Permanent **Work mode** On-site **Shift** Day shift **Work schedule** Full-time **Working hours*** 6:30 AM to 4:36 PM, Monday to Friday **Education** Bachelor's degree with professional title **English** Spoken: Advanced, Written: Advanced **Willingness to travel** No
Juan García
Indeed · HR
Juan García
Indeed · HR
