Post Market Quality Specialist CR

Job Title

Job Title

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.

Job Identification 11158

Job Category Quality & Regulatory Affairs

Degree Level Bachelor's Level Degree

Job Schedule Full time

Locations Alajuela, Costa Rica