Post Market Quality Specialist CR; Temp

Job Description

Summary of

Duties and Responsibilities:

• 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:

• Drive for Results
• Planning
• Problem Solving
• Communication

Education:

• University bachelor's degree in engineering or similar.

Experience:

• No experience required.

Specialized Knowledge (Desirable):

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

Languages required for the position (Desirable):

• Spanish/English (Advanced level)

Computer tools and knowledge level required (Desirable):

• Microsoft Office, Minitab, Oracle, Agile

• Job Identification 11918
• Job Category Quality & Regulatory Affairs
• Posting Date 07/07/2026, 08:28 PM
• Degree Level Bachelor's Level Degree
• Job Schedule Full time
• Locations Alajuela, Costa Rica