Post Market Quality Specialist 2 CR
- 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.
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Make decisions following a risk-based approach, implement tools such as FMEA, Fault Tree Analysis (FTA) and risk evaluation.
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