Descripción y detalle de las actividades
· becomes process expert of all process and equipment in the production area.
· creates and maintains process work instructions associated with all manufacturing processes such as manufacturing assembly and in-process acceptance procedures.
· develop and implement visual aids and physical samples on critical steps of the process to indicate proper acceptance criteria.
· trains manufacturing staff to released work instructions.
· specifies, procures, installs, and validates manual, semi-automated and fully automated equipment.
· develops and execute process validation protocols or/and transference plans and generates test reports.
· creates and maintains process risk assessments, pfmea.
· supports investigation, disposition, and corrective action of non-conforming materials.
· establishes statistical process controls (spc) for manufacturing operations.
· develops and maintains world class manufacturing practices to ensure capability for the company's products.
· develops and implements cost reduction/process improvement programs.
experiencia y requisitos
• b.s. in mechanical engineering, electrical engineering, manufacturing or industrial engineering
• technical experience working in high-volume manufacturing environment.
• experience in application of statistical process controls in a manufacturing environment
• experience in manual, semi-automated and automation processes, verification and validation
• hands-on skills with electro-mechanical troubleshooting and diagnostics
• excellent technical writing abilities
• excellent conceptual, analytical, and problem-solving abilities.
• excellent computer skills - cad, word processing, and spreadsheets.
• ability to be part of a team and adept in building and leading teams.
• knowledge and experience in fda qsr requirements and preferably iso-13485 requirements.
• experience with planning and executing process validations and managing process risk assessment.
• knowledge on developing and executing saving projects thought lean manufacturing techniques.
• good spanish and english communication skills, both verbal and written, and the ability to effectively interface
beneficios
beneficios superiores a lft