Descripción y detalle de las actividades
Quality Engineer I is responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement, collaborates with cross-functional teams to address quality issues, drive continuous improvement, and contribute to building high-quality products that exceed customer expectations. Quality Engineer possess a strong background in engineering or quality assurance, attention to detail, and a proactive mindset. - Contribute to all cost saving and safety initiatives and related CIS programs. - Generate and maintain process requirements, specifications, validation and confirming quality documents to assure product / component conformance. - This position can develop and manage Quality Engineering Technicians. - Execute test method validations and Engineering Tests. - Develop and maintain FMEA's and Control Plans. - Perform, maintain, and sustain activities under QMS. - CAPA, NMCRs and Customer complaints root cause investigations are completed in a timely manner. - Coordinate and/or contribute in DHRs processes. - Generate a weekly and monthly reports using quality objectives. - Provides support during customer visits. - Set detailed guidelines on what needs to be checked and what the quality standards are. - Update the Quality Management System (QMS) with incidents, fixes and improvements. - Audit our quality systems based on standards requirements. - Monitor the entire production cycle and perform regular tests to identify potential malfunctions as early as possible. - Inspect product for defects and identify the root of technical issues and recommend fixes. - Prepare reports on malfunctions and corrective actions. - Review quality documentation - Set and track quality assurance goals. - Coordinate with external quality assurance auditors and technicians to ensure legal compliance. - Work with internal teams to increase customer satisfaction by improving the quality of the products.
Experiência y requisitos
- Bachelor's degree in engineering (industrial, chemical, manufacturing or any other related). - Ideal to have previous experience in Medical Devices / Quality System ISO 13485 - And/or is preferable required at least 2 years of experience in similar position. - Advanced Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases. Etc.). - Capability to train and develop people. - Knowledge of National and International Standards related to quality. - Certification Desirable (Green Belt, Certified Lead Auditor, Certified Quality Engineer, or any other related.) - Knowledge of ISO 14001 Environmental management System
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Titulo Profesional
**Sexo** Indistinto
**Disponibilidad p. viajar** No