QRC Group, Inc
Pharmaceutical, Medical Devices, Chemical
CAPA/ComplaintsTechnicalWriter
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“CAPA/ Complaints Technical Writer at QRC Group, Inc. Skills: CAPA documentation, Complaint handling, Technical writing, Regulatory compliance. Author CAPA documentation. Maintain CAPA documentation”
What You'll Achieve.
Ensure documentation is inspection-ready; Ensure documentation is compliant; Support timely closure of quality records
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
3+ years technical writing experience, 5+ years experience in regulated environment, Experience authoring CAPA documentation, Experience authoring complaint documentation, Experience authoring investigation documentation, Experience authoring quality system documentation, Root cause investigation methodologies, Risk Management (ISO 14971), FDA regulations, ISO 13485 regulations, MDSAP regulations, EU MDR regulations, Quality Management Systems (QMS), Document control practices
What You'll Do.
Author CAPA documentation
Maintain CAPA documentation
Author complaint documentation
Maintain complaint documentation
Author investigation documentation
Maintain investigation documentation
Author remediation documentation
Maintain remediation documentation
Draft root cause analyses
Draft corrective action plans
Draft effectiveness checks
Draft investigation reports
Document investigation outcomes
Support quality system remediation
Support regulatory inspections
Standardize documentation practices
Support continuous improvement
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality team; Engineering team; Regulatory Affairs team; Operations team
Communication Scope
Technical documentation
Full Job Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com / to learn more about our services and solutions! 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, 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. ## Qualifications * 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 q
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