Cornelio Garay

Responsible to maintain the QMS working and updated. Chair the QMS audits for ISO 9001, Customer or Internal Audits. Chair the Management and KPI Review meetings and author the management review reports. Ensure all procedures, work instructions and records conformances to ISO standards. Lead the customer complaints investigation and awareness notification to the staff and associates. Support customer and supplier credits, returns, and off-specification material allocations. Lead the prevention techniques versus inspection methods, set the tone for continuous improvement in products, processes, systems, equipment, training and development of associates.

Oversee the coordination and development of test methods, evaluate and recommend new testing techniques or equipment for incoming or outgoing materials, keep abreast of new equipment innovations. Supervision of Daily QC Inspection in process including on time testing & releases, Technicians Administration (over time, permits). Communication direct with Production & Engineering on any quality issues. Responsible to keep and sustain a good quality system for process control, establishing the same quality criteria for all shifts (Standardization). NCMR follow up and escalation to CAR when applicable. MRB Disposition Execution & Closure. Coordinate the PPAP execution and documentation.

Responsible to develop and validate Visual and Dimensional Inspection Methods (TMV, MSA), including the design and develop of fixtures and programming automatic measurement routines for use with the Vision System equipment (Nikon). Support to New Product Launch projects on validating new products. Responsible for the Management of Calibration Program & Environmental Controls (Particle counts) for the whole plant. Responsible for the clean room annual certification. Responsible to create, update and implement standard procedures, work instructions, quality inspection plans, visual aids and related forms. Perform internal audits for Quality Management System based on ISO 13485. Support QMS audits for ISO 13485, Customer or Internal Audits.

Responsible of performing functional test of raw materials, finished goods and prototypes by using measurement and test equipment such as rheometer, tensiometer and durometer. Release or reject raw material and finished goods based off Testing Results. Perform Chemical Concentration Analysis in the metal treatment process. Responsible for the First Article Inspection (FAI). Responsible for the Management of Calibration Program. Responsible for the Document Control Process. Perform internal audits for Quality Management System based on ISO 9001.