QA Production Engineer I Medical Industry Job Functions Review and compile DHR's for each lot of finished products to verify compliance with good documentation Practices, perform the final Quality release and generate COA. Responsible for reviewing, approving, and releasing functional reports performed. Manage database of the released lots and the components used on each lot to ensure traceability. Reconciliation of released finished product and SCRAP quantities. Ensure produced quantity of final product is aligned with customer work orders. Transfer of DHR's using the electronic platform designated by customer. Assign lot numbers for different manufacturing processes. Oversee activities of QA production crew. Assist in the coordination of QA resources for the different manufacturing processes and overtime needs. Manage Supplier Control program and maintain ASL. Generate Quality Agreements and Supplier Surveys. Conduct Supplier Audits and generate reports. Evaluate Manufacturing Deviations and support resolutions. Conduct Internal audits and generate audit reports. Assign, capture, and control equipment and process validation numbers as required by engineering. Responsible for generating, maintaining, and controlling Asset Numbers, and facility Inventory Numbers. Participates in activities related with the preparation of external audits. Act as a SME for QA production processes and Supplier Control during external audits. Assist in the creation of reports and charts for the Measurement of KPI's related to the quality department. Be an active enforcer of good manufacturing practices inside and outside the quality department. Assist in product rework activities, generating forms for the in-process and final release inspections and controls required for quality assurance. Knowledge and Requirements 5 years of experience in Quality Assurance Bachelor’s Degree English level (advanced) Knowledge of QSRs & ISO 13485:2016 To work Monday to Friday from 7:00am to 5:00pm at the El Pacífico industrial park. Knowledge of the medical industry is essential. #J-18808-Ljbffr