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
* minimum of 5 years of professional experience in quality assurance, preferably in regulated industries.
* bachelor’s degree in engineering, life sciences, or a related field.
* advanced english proficiency, with strong written and verbal communication skills.
* solid knowledge of quality system regulations (qsrs) and hands-on experience with iso 13485:2016 standards.
* demonstrated ability to apply quality requirements to procedures, documentation, audits, and continuous improvement initiatives.
location: parque industrial el pacífico
schedule: monday to friday, 7:00 a.m. to 5:00 p.m.
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