CAPA Complaints Technical Writer

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.

• 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.
  

Requirements

• Bachelors 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