Duties and responsibilities reviews and investigatesproduct problems and/or customer complaints or othernonconformities, including evaluating the quality system;determination of root cause and recommend corrective and preventiveactions where required (complaints, capas and ncrs).
providequality support in products as well as in project development.
actas quality representative for quality issues in transfer products.lead projects related to the improvement of products and processes.provide feedback to manufacturing engineering to reduce rejects andreduce non-conforming material.
use quality tools to solve problemsrelated to your business unit.
formulate and present statisticaldata reports and monitoring of your business unit.
provide supportand support in validations of manufacturing processes in yourbusiness unit.
carry out inspections and/or tests of products, rawmaterials, equipment or accessories according to establishedspecifications using special test equipment including wherenecessary development of test equipment specifications andprotocols.
participates in mandatory business unit meetings andweekly meetings and prepares and presents information anddocumentation associated with quality engineering activities.provide support to internal audits as well as the preventiveidentification of opportunities for improvement in processes andquality system.
support in the administration of new revisedmethods when required.
execute and comply with the specificactivities and requirements described by the documented qualitysystem.
know and apply the policies and procedures of the qualitysystems, iso 13485, occupational safety, and any other system thatthe company requires for its operation.
this position may havepersonnel under its responsibility (quality inspectors).
experienceand requirements engineering degree from a 4+ year universityprogram.
3-5 years of experience in quality engineering in themedical device manufacturing industry.
experience in fdaregulations of medical products excellent ability to communicateorally and in writing in english/spanish.
knowledge of qualitysystems required in relation to iso13485