QRC Group, LLC

CAPA / Complaints Technical Writer

📍 Location
Cidra, PR
⏰ Job Type
Full-time
📅 Posted
June 06, 2026
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Job Description

The CAPA / Complaints Technical Writer is responsible for authoring, reviewing, and maintaining high-quality documentation associated with Corrective and Preventive Actions (CAPA), customer complaints, investigations, non conformances, and Quality Management System (QMS) remediation activities within a regulated medical device environment. This role ensures that all documentation is scientifically sound, technically accurate, inspection-ready, and compliant with applicable regulatory requirements. The Technical Writer partners with cross-functional teams to support timely closure of quality records while developing clear, concise, and compliant investigation reports, root cause analyses, effectiveness checks, and remediation documentation. Responsibilities: Author and maintain CAPA, complaint, investigation, and remediation documentation. Draft root cause analyses, corrective action plans, effectiveness checks, and investigation reports. Collaborate with Quality, Engineering, Regulator...

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