Post Market Quality Specialist 1 CR (Temp 12 months)

Hologic · Alajuela

Education / Educación:
University bachelor’s degree in engineering or similar.

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

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades

Prepare Post Market Surveillance Review Board meetings according to business needs.
Escalate to his/her supervisor if a statistical signal is identified when preparing Review Boards.
Facilitator on low complex to moderate investigations and conduct timely and insightful response to investigations.
Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Maintain data mining tools to monitor trends.
Participate in product transfers.
Facilitates cross functional meetings, as needed.
Maintain, improve, and simplify procedures, processes, and methods.
Participate in Internal and External Audits/Inspection and Assessments.
Make decisions based on risk thinking, PFMEA, Fault Tree Analysis (FTA) and risk evaluation.
Support other roles in the PMS organization:
- Assess complaints and escalate potential adverse events.
- Investigate physical returned units.
Qualifications / Cualificaciones:
Drive for Results
Planning
Problem Solving
Communication