The Quality Engineer supports the Quality Management System (QMS) to ensure compliance to the regulatory and procedural requirements in the manufacture of medical products.
Will assist the assigned Value Stream Business Unit in the establishment and implementation of programs designed to assure control of processes and products toward the established standards of quality under the Company QMS.- Provides oversight and approval of IQ, OQ, PQ validation protocols, execution, and reports on new and sustaining products.- Oversees PPAP activities and produce PPAP submittal packages on new and sustaining products.- Participates as a member of the FMEA team related to primarily new and developing products.- Develops and documents control plans.- Conducts statistical capability studies and sets up SPC control charts.- Documents inspection procedures and test methods.- Performs regular audits of processes and materials to ensure that: Inspections, tests, and operations are being conducted and documented according to applicable specifications and standard operating procedures.
Assures the results of inspections and tests are in compliance with all applicable requirements.- Monitors final release of finished product based on above audits.- Monitors and interprets SPC charts to assure that processes remain in control.- Directly interfaces with production in the operator training process for quality issues.- Reviews reject reports and initiate corrective action as required.- Directly interfaces with other support departments as required.- Completes special testing when required for failure analysis, validations, etc.- Sets up inspection/test equipment.- Observes all safety regulations and procedures.- Follows all department and company policies and procedures.- BS in engineering, or related science.- 5 years of medical device manufacturing experience as a Quality Engineer.- Experienced in IQ, OQ, PQ validations.- Good working knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology, and SPC.- ASQC Certified Quality Engineer preferred.- Competent in Microsoft Office Suite, including Word, Excel, Power Point and Visio.- Ability to interact with all levels of the organization and with suppliers.- Strong written and oral communication skills.- Strong analytical skills in problem analysis and problem solving.Tipo de puesto: Tiempo completo, Por tiempo indeterminadoSalario: $1.00 - $2.00 al mesPuede trasladarse/mudarse:- Tijuana, B.C.
: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Deseable)