Quality Management System Engineer

hace 2 días

Mexicali, México Envista Holdings A tiempo completo

**Control of quality system documents and records**:- Coordinates the updating and maintenance of procedures and other quality system documents.- Performs issuance and distribution of procedures, work instructions, formats, visual aids and other quality system documents.- Administers the quality system training system.- Maintains quality system records; such as: TR's, MRDR's, complaints, CAPA's, GMP's, variances, audit reports and BSI, FDA, COFEPRIS, etc. certificates.**Quality System Administration**:- Collaborates in the preparation and coordination of the internal quality system audit program.- Participates in external audits of the quality management system: ISO 13485, GMP, COFEPRIS, FDA and other regulations.- Performs internal quality system audits and patrols on good manufacturing practices for medical devices.**Reports**:- Prepares monthly QA KPI's report.- Prepares monthly GMP's and MRDR's report.- Collaborates with the monthly CAPAs meeting presentation.- Collaborates with the presentation of the management review meeting.**Training and Development**:- Attends all required courses, seminars and workshops in a mandatory and timely manner.**Other**:- Follow up of PSR's, complaints and CAPAS.- Collaborates in specific projects of control and improvement of the quality system.- Trains department personnel on specific topics.- Gives induction training to new personnel.**Job Requirements**:**Requirements**:- Industrial Engineer, LAE or related.- Basic knowledge in blueprint reading and measuring instruments.- Knowledge of ISO 13485 is desirable.- Preferably experience in a similar position.- English language and good writing skills are desirable.- Knowledge in the use of Microsoft Office.- Service attitude.- Availability.- Communication and training skills.**Operating Company**:Ormco

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