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