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