CAPA / Complaints Technical Writer

The CAPA / Complaints Technical Writer<\/b> 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.

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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.

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Responsibilities span>

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Author and maintain CAPA, complaint, investigation, and remediation documentation span>

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Draft root cause analyses, corrective action plans, effectiveness checks, and investigation reports span>

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Collaborate with Quality, Engineering, Regulatory Affairs, and Operations teams to document investigation outcomes span>

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Ensure compliance with FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR requirements span>

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Support quality system remediation projects, audits, and regulatory inspections span>

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Standardize documentation practices and support continuous improvement initiatives span>

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Requirements<\/h3>

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 span span>

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Experience authoring CAPA, complaint, investigation, or quality system documentation span>

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Root cause investigation methodologies (5 Whys, Fishbone, Fault Tree Analysis)<\/span>

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Risk Management (ISO 14971)<\/span>

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FDA, ISO 13485, MDSAP, and EU MDR regulations<\/span>

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Quality Management Systems (QMS) and document control practices<\/span>

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