Silvia Ramirez Email & Phone Number

QMS implementation, development and improvement based on ISO 9001 & ISO 13485 standards. •Maintained and measured the effectiveness of the Quality System based inspection systems, policies, procedures, records, corrective actions and audits for medical decides and industry products. •Management reviews, Quality Audit Program including external and internal audits, corrective actions and follow up. GMP’s, FDA QSR for manufacturing medical devices, ensures compliance with applicable regulatory bodies.•High experience in Quality Assurance, Manufacturing and Process engineering for plastic injection molding industry. •Plan, organize and direct the activities of the quality staff ensuring to provide the necessary technical support to manufacturing, engineering, planning and maintenance areas to achieve organizational objetives. Serves as liaison with manufacturing operations and engineering staff to improve product processes. •Provide technical support to all customers on quality and engineering issues as well as identify and assist in resolution of all quality problems affecting output. •Manage pre-production validation activities for customer approval: First articles inspection (FAI), (SPC), CPK's, Control Plans, Process Capability Analysis, perform root-cause analysis and other problem solving activities, calibration, metrology, geometric dimensioning and tolerance. Validations & Qualifications for new products (IQ/OQ/PQ), NPI•Established metrics for Quality Department and support other areas for metrics establishment. Generates metrics for cost of quality and other quality metrics as needed to support achievement of goals and reduce non conformances.•Implemented Preventative Maintenance procedures and operational controls for facility, machinery (company and customer’s tools and equipments), environment,warehouse, production and tooling areas.•Leadership, coaching, mentoring, training, directing and job assignments of Quality Department staff.

Listed skills include Process Improvement, Manufacturing, Project Management, Product Development, and 11 others.

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  Instituto Tecnologico De Mexicali

  Engineer’S Degree