Post Market Surveillance Specialist 1

📋 Description

• • Own the end-to-end life-cycle of every post-market complaint from initial intake through final closure, ensuring that each case is documented, coded, and tracked in strict accordance with FDA 21 CFR Part 820, ISO 13485, and Fresenius Medical Care’s global Quality Management System.
• • Act as the primary liaison between patients, caregivers, customer service, sales, marketing, manufacturing, and Corporate Quality Engineering to gather missing data, retrieve suspect devices or samples, and drive timely, evidence-based investigations that protect patient safety and uphold product integrity.
• • Receive, triage, and accurately enter complaints arriving via phone, e-mail, fax, CRM portals, and verbal reports into the validated Complaint Management Database within 24 hours of receipt, applying GDP, ALCOA+ principles, and the master symptom/severity code list to ensure traceability and regulatory readiness.
• • Draft and send professional acknowledgement and response letters to customers and patients in both English and Spanish, providing empathetic preliminary support, clear timelines, and next-step expectations that strengthen trust in the Fresenius brand.
• • Partner with RTG manufacturing sites and Technical Service teams to verify the correct status of durable equipment reports before system transfer, eliminating duplicate entries and preventing data integrity gaps that could trigger audit findings.
• • Perform weekly and ad-hoc queries using Crystal Reports, MS Access, and advanced Excel functions to extract complaint data, identify emerging safety signals, and generate trend analyses that feed directly into CAPA, risk management files, and executive dashboards.
• • Review completed investigation packets for completeness, accuracy, and consistency; ensure that root cause, corrective action, risk assessment, and clinical evaluation sections are present and aligned before authorizing formal closure of complaint files.
• • Maintain a personal accuracy rate of ≥95 % on all data entry, coding, and correspondence activities, participating in quarterly internal audits and external FDA/Notified Body inspections with zero critical observations.
• • Contribute to cross-functional process-improvement projects—such as complaint form redesign, e-signature workflows, or AI-assisted coding pilots—that reduce cycle time, enhance user experience, and strengthen global regulatory compliance.
• • Champion the Fresenius Compliance Program by staying current on MDR, IVDR, and FDA guidance documents; complete all assigned training modules on time and mentor junior specialists on GDP, risk-based thinking, and bilingual customer communication.
• • Foster a culture of curiosity, humility, and collaboration by sharing lessons learned during monthly Quality huddles, celebrating team wins, and volunteering for sustainability initiatives that align with Fresenius’ mission of “caring for life.”
• • Thrive in a fast-paced, multicultural environment where self-discipline, hard work, and truthfulness are valued; seize every opportunity to make a tangible difference in the lives of more than 345,000 patients worldwide who depend on Fresenius therapies every day.