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
- 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
Skills Required
- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Technical Communications, or 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
- Knowledge of root cause investigation methodologies (5 Whys, Fishbone, Fault Tree Analysis)
- Risk management experience (ISO 14971)
- Familiarity with FDA, ISO 13485, MDSAP, and EU MDR regulations
- Experience with Quality Management Systems (QMS) and document control practices
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
