Job Description

• 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

• 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.