Empresa líder mundial en componentes industriales,Automotriz, y Medica. Una de las mejores Empresas para trabajar en Tijuana Great Place to Work.
•Seguro de vida y GMM
*Aguinaldo 20 días
•Fondo de ahorro
•Servicios médicos en planta
Evaluates manufacturing and supply chain processes to determine strategies, action plans, and programs which provide greater productivity and efficiency of company functions by performing the following duties:
Responsible for developing and coordinating process / equipment validations & software validation protocols, risk analysis testing systems used to develop or manufacture products, maintain our procedures updated, processing engineering changes, releasing and implementing ECOS Internal & Engineering Changes.
Evaluate, develops strategy for Master Validation Plan (MVP) and transfer of new products and process.
Performs Risk Assessment and Regulatory evaluations. Generates Temporary Deviations and internal failure reports Incident Report (RI). NCMR non-conforming material reports (MRB). Item Master, Product Structures (BOM), Routings, work centers, labor classes, costing etc. Coordination of cost reduction projects.
The introduction of Customer engineering changes, its validation strategy and its related documentation generation/update, such as time studies, line layouts, operating procedures, DHR, drawings, engineering studies, DQ, IQ, OQ and PQ protocol and reports, among others.
Position requires thorough knowledge of ISO 13485, CFR Part 820, CFR part 11, GMP, process validation, lean manufacturing industrial and engineering techniques.
Desirable knowledge of ISO 13408, CFR Part 211, ICH and MDSAP.
BS degree in Engineering. (Mechanicalor Industrial Engineering) or equivalent
Bilingual English / Spanish, two US / Mexico cultures.
Knowledge and experience on the use of quality tools: SPC, Pareto analysis, GR&R, capability studies, P/D FMEAs, Control Plans, PPAP, CAPA, 8D.
Involve customer, production, maintenance, quality, engineering and materials personnel in a team approach to problem solving and continuous improvement and assure that all issues are properly resolved and communicated.
Knowledge of Process Capability Studies, PFMEA, Six Sigma and Lean manufacturing
* Green Belt certification on Six Sigma Methodology.
* Ability to detect and solve problems identification of root cause.
* Willingness to travel within and outside the country.
* Strong project management skills and ability to manage and develop teams.
*The Engineer must have a “can do” attitude and must be hands-on and will work towards goals.
*Experience with Plastic Molding Lim and thermoplastics, cryo process, secondary operations
*Multi-tasking with ability to prioritize.
*Strong computer skills in MS Office, Project or equivalent, *Minitab, Solid Works.
*A self-starter who is organized and energetic with a strong work ethic.
*Strong project management skills and ability to manage and develop teams.
*Ease of communication at all levels, inter-departmental relation
**** Interesados posturlarse en nuestra base de datos www.empleosgse.com***
|Horario||Lunes a viernes|