The Opportunity This position works out of our Alajuela, Coyol location in the Vascular division that provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.What You'll Do Apply quality principles, analyzes quality records, prepares reports and recommends improvements.Conduct inspection, verification and validation of components or materials used in development processes.Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.Document quality issues and performance measures for management review.Interfaces primarily with internal company contacts and begins an extensive external network.Plans and conducts small- to medium-size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment.Anticipates future directions. Benchmarks internally and externally.Independently investigates, conducts tests or experiments, gathers data, and performs preliminary analysis. Reports findings. Prepares and communicates recommendations and respective action plans.Builds relationships. Initiates and cultivates open, honest relationships with colleagues, developing an understanding of others' needs.Identifies and Evaluates areas of risk with respect to compliance, Product/Mfg performance, Develops procedures, maintain FMEAs.Resolves problems, such as production process deviations, non-conformances (CAPA), field product performance, urgent out-of-stock replacements, and crisis situations requiring fast, astute decisions with rapid implementation by utilizing technical training and experience.May work in combination with SQE and Receiving Inspectors focused on driving improvements and CAPA in the quality of components sourced from outside suppliers.Provides technical support in the supplier corrective action, manufacturing yield and field failures.Shift: Admin (Monday – Friday from 8:00 am to 5:00 pm)On-Site positionRequired QualificationsBachelor's degree in engineering or related STEM field4 years of related experiencePreferred QualificationsQuality Background desired.FDA/ISO regulation knowledge.CQE / CQA / Lean/ Six Sigma certification is desired.Statistic's basic knowledge.Personal skills needed include Accountability, tact, open-mindedness, maturity, tenacity, decisiveness, nimble learning, Scientific thinking, Diligency, Resourcefulness, customer focus. Capable to persuade and motivate others to improve quality. Effective communication skills.
