Senior Quality Engineer - Tijuana, México - Corza Medical Tijuana
Descripción
y detalle de las actividades
What you will do - Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional - Monitor and maintain the quality system to comply with all applicable regulatory requirements including FDA QSRs, ISO, Medical Device Directive and other applicable standards and/or guidelines - Design and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.
Use concepts of probability and statistical quality control to guide decisions - Works closely with operations and the business functions to ensure quality performance of product and processes - Maintains KPIs for monitoring of process and/or product quality, performs analysis, and interprets trends.
Leads process improvements - Review non-conformance reports and materials with production and engineering personnel to identify corrective actions - Participates in the development and review of process and equipment validation/qualification and MSAs.
- Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes - Review manufacturing processes to develop preventive actions - Direct the tracking and statistics of defects, test results or other regulatory quality data.
- Review and approve validation / qualification, Material Reports and other QA documents for compliance with business practices and departmental procedures and policies - Performs other related duties as assigned or requiredExperiência y requisitos
What you will need - Degree in Engineering (Mechanical or Electrical preferred) or equivalent certification and work experience - Minimum of 5+ years of working experience in engineering, quality or manufacturing within a medical device company - Strong validation understanding - Automation background preferred - Experience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook) - Strong time management skills to ensure prioritization and organization to meet deadlines of multiple projects - Experience problem solving and lean principles - Strong communication skills.
Número de vacantes 2
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Horario L / V
Estudios Carrera Profesional
Sexo Indistinto
Disponibilidad p. viajar No
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