About this role
• Education / Educación: • University Bachelor's degree in Engineering or similar.
• Experience / Experiencia: • 2 years on position of similar responsibility, decision making and problems resolution.
• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): • FDA regulations, ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards. • Statistics.
• Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): • Spanish/English (Advanced level)
• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: • Microsoft Office, Minitab, Oracle, Agile and H1.
• Qualifications / Cualificaciones: • Drive for Results • Planning • Organizational Agility • Listening • Decision making • Problem Solving • Communication
• Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades: • Prepare and present Post Market Surveillance Review Board meetings for the products under her/his responsibility. • Ensure PMS RB records are released in the PLM system on a timely manner. • Facilitator of low to moderate complexity investigations and conduct timely and insightful response to investigations. Work on moderate problems where analysis of situation or data requires a review of a variety of factors. • Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints. • Identify unacceptable trends and ensure application of suitable corrective actions to reduce defects / meet quality objectives (when required). • Facilitate investigations for emerging issues. • Complete Post Market Surveillance documentation as PMS Plans, PMS Reports, Periodic Safety Update Reports (PSURs), Canadian Summary Reports and similar documentation. • Provide complaint data for clinical documents such as Post Market Clinical Follow up (PMCF) and Clinical Evaluation documents. • Responsible for planning PMS Reports, PSUR and Canadian Summary Reports cadence. • Maintain data mining tools to monitor trends. Define Control and / or Action Limits to detect emerging field issues. • Participate in product transfers. • Support Health Risk Assessments (HRA) and Health Hazard Evaluation (HHE) processes. • Lead and facilitate cross functional meetings, as needed. • Provide guidance to the PMS Team on the investigation process of her/his products. • Maintain, improve, and simplify procedures, processes, and methods. • Participate in Internal and External Audits/Inspection and Assessments. • Make decisions following a risk-based approach, implement tools such as FMEA, Fault Tree Analysis (FTA) and risk evaluation.