Post Market Quality Specialist 1 CR (Temp 12 months)

Costa Rica·Alajuelamid

Manufacturing & ProductionQuality Manager

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Key Responsibilities

Assess complaints and escalate potential adverse events. Investigate physical returned units.

Requirements Summary

Drive for Results Planning Problem Solving Communication

Technical Tools

Manufacturing & ProductionQuality Manager

FDA regulations, ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards.

Statistics.

Spanish/English (Advanced level)

Microsoft Office, Minitab, Oracle, Agile

~1 min read

→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.
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Support other roles in the PMS organization:
- →Assess complaints and escalate potential adverse events.
- →Investigate physical returned units.