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, analyze quality records, prepare reports and recommend improvements.Conduct 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 metrics for review boards.Interfaces with internal company contacts and external networks.Plans and conducts high-level assigned projects within quality specialties requiring conventional types of plans, investigations, and/or equipment.Anticipates future directions. Benchmarks internally and externally. Recognizes changes in the environment and present resources as indicators of future problems and opportunities; prepares for such eventualities.Independently investigates, conducts tests or experiments, gathers data, and performs preliminary analysis. Reports findings. Prepares and communicates recommendations and respective action plans.Predicts patterns/trends. Grasps complexities and sees relationships among data; determines consequences and alternatives; makes recommendations.Mentors others by sharing technical expertise and providing feedback and guidance.Builds relationships. Initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others' needs, promoting common goals, and following through on commitments.Identifies and evaluates areas of risk concerning compliance, Product/Mfg performance, develops procedures, and maintains FMEAs.Resolves problems and provides guidance, such as production process deviations, non-conformances (CAPA), field product performance, urgent out-of-stock replacements, and crises requiring fast, astute decisions with rapid implementation by utilizing technical training and experience.Shift: Admin (Monday – Friday from 8:00 am to 5:00 pm)Education:Bachelor's Degree: Engineering, science or closely related discipline is desired, or equivalent technical.Required Qualifications5 years of experience in medical devices or related industries.Fully Bilingual (English and Spanish) I RequiredPreferred QualificationsQuality Background.FDA/ISO regulation knowledge.CQE / CQA / Lean/ Six Sigma certification is desired.Statistic knowledge.Personal skills needed include Leadership, accountability, tact, open-mindedness, maturity, tenacity, decisiveness, self/reliance, scientific thinking, diligence, Resourcefulness, and customer focus. Capable to persuade and motivate others to improve quality. Effective communication skills. Leadership skills.
