Diego Ulate Email & Phone Number

Coyol, Alajuela, Costa Rica

Lead new product development project, assuring design inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.Responsible for co-leading Design Control Phase gate reviews and signatory on product development documentsResponsible for supplier and material qualification activities related to new product developmentsResponsible for process validation activities when required as part of the Design Transfer to manufacturing.Review, creates and edits technical files and design control documents for medical devices.Lead and coordinate review meetings to present to management updates and status of projects.Compile Design history files in accordance with ISO 13485, ISO 14971 Risk Management and IEC 60601 and other applicable US, EU and International regulations.Assess change requests of product or process for impact to design, determine supporting information required for the implementation of changes

Costa Rica

Responsible for the activities of implementation, maintenance and continuous improvement of the quality system processes.Responsible for the risk management process (Risk Management Plans, FMEA, Risk Reviews, Gap Assessments, risk control implementation, etc.).Responsible for supplier and material qualification activities related to new product developmentsResponsible of the management and execution of internal and supplier audits.Execute process validation (creation of protocols/reports, IQ, OQ, PQ, DOE) and software validations (CSV). Creation of quality system documents (SOPs, Work Instructions, etc.).Execution of root cause analysis, as well as the definition and implementation of corrective actions for non-conforming events related to the different quality/manufacturing processes (NCR, CAPA).Coordinate microbiological monitoring and other activities to maintain environmental conditions. Monitor the manufacturing process to verify that the product meets customer requirements, as well as the creation and proper use of manufacturing documents (DHRs, CofCs, Drawings).

San Pedro De Montes De Oca

Define functions, evaluate and monitor the fulfillment of staff tasks.Design study programs tailored to needs based on assessment data. Negotiation, resolution and monitoring of conflicts between students, between faculty professors, and between faculty and students.Teach organic and inorganic chemistry to colleague students

Coyolar, Alajuela, Costa Rica

Acquisition, custody and adequate conservation of chemical substances.Management of sanitary operating permits, preparation of transport records, management and disposal of chemical waste, preparation of reports and monitoring of movement of precursors, Registration of industrial chemicals in the Health Ministry.

Coyol, Costa Rica

Development of test methods, inspection and process validation. Nonconformity management (CAPA, NCR, SCAR, FMEA).Qualification, management and audits of new and existing suppliers.Responsible for supplier and material qualification activities related to new product developmentsVerify compliance with international regulations such as FDA China Rohs, etc.Issue and follow up on suppier corrective actions requests (SCARs)