Descripción

QA Production Engineer

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