Sr. Quality System Engineer

• Jul 2022 - Present

Quality System Engineer IV

• Jan 2022 - Jul 2022

Provides Quality System Body of Knowledge support to the organization. Lead cross functional teams to execute Quality System initiatives. Participate in or lead teams in supporting quality disciplines, decisions, and practices. Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations. Support and execute internal/external Quality System audits. Ensures compliance to all Quality System Regulations and policies applicable to SH Structural Heart/ CAHF Cardiac Arrhythmias & Heart Failure units in Costa Rica by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements. Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to SH Structural Heart/ CAHF Cardiac Arrhythmias & Heart Failure units in Costa Rica. Supports, executes and resolves investigations related either to non-conformances or improvement opportunities. Works with the organization during new product introductions to ensure quality deliverables such as Quality Plans and Risk Management are in place for the products being transferred. Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions. Supports the CAPA System elements for the site Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Might be responsible for specific areas within the quality systems organization, driving for excellent operative execution and personnel management (facilitation, training and development). Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Show less

Quality Systems Engineer

• Jun 2018 - Jan 2022

Manage the CAPA process including review and approval of CAPA documentation.Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to S+N.Supports, executes and resolves investigations related either to non-conformances or improvement opportunities. Leads internal audit program.Monitoring of QS, CAPA, NC, Management Review metricsHead of preparation / execution of the Management ReviewManage coordination and preparation of external auditsProvides Quality System Body of Knowledge support to the organization. Lead cross functional teams to execute Quality System initiatives. Participate in or lead teams in supporting quality disciplines, decisions, and practices. Lead Auditor ISO13485: 2016 - BSI Show less

Quality System Jr. Engineer

• Mar 2016 - Jun 2018

Manage the CAPA processReview and approval of CAPA documentationCollaboration in the administration of the QS internal audit programMonitoring of QS, CAPA, NCR, Management Review metricsPreparation of minutes related to CAPA & Internal AuditsHead of preparation / execution of the Management ReviewIn charge of the coordination and preparation of internal and external auditsInternal Auditor ISO13485: 2016 - BSI

SAP Calibration Specialist

• Feb 2014 - Mar 2016

Coordinate national and international calibrations.Approvals of new equipment and creation of calibration plans in SAP.Metrics and schedules related to Calibration.Creation of Investigations of equipment out of tolerance in SAP.Updates on equipment specifications for improvements in the Quality system.Knowledge of Agile systems (ORACLE) and SAPSupport to the Department of Calibrations and Engineering.CR Support person in SAP system Validation for the area of calibrations and preventive maintenance.Train the personnel in SAP CAL Module. Show less

RMA Specialist

• Jun 2012 - Feb 2014

Knowledge of Agile systems (ORACLE) and SAPSupport to the Department of Calibrations and Quality EngineeringSupport Project of New SAP Module for the Calibration and Preventive Maintenance Area

Doc Control Clerk II

• Feb 2012 - Jun 2012

Training to new personnel, in databases (Agile) and training system (Pilgrim) used in the company.Knowledge and training in AGILE (ORACLE) in addition to training control software.Control of training records of personnel in the company and updating the company's training database.