CAPA / Complaints Technical Writer

QRC Group, LLC • Cayey, PR

3d

About The Position

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.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Technical Communications, or a related scientific discipline.
• 5+ years of experience in a regulated industry
• 3+ years of technical writing experience in medical devices, pharmaceuticals, biotechnology, or similar regulated environments.
• Experience authoring CAPA, complaint, investigation, or quality system documentation.
• Root cause investigation methodologies (5 Whys, Fishbone, Fault Tree Analysis)
• Risk Management (ISO 14971)
• FDA, ISO 13485, MDSAP, and EU MDR regulations
• Quality Management Systems (QMS) and document control practices

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, Regulatory Affairs, and Operations teams to document investigation outcomes.
• Ensure compliance with FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR requirements.
• Support quality system remediation projects, audits, and regulatory inspections.
• Standardize documentation practices and support continuous improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior