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CAPA/ Complaints Technical Writer
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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. 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.

Requisitos:
 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

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Cayey PR 00600 Cayey
DescripciónDescription 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. 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. Requisitos 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
Requiere Mucha Experiencia Requires Expert
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QRC GROUP LLC

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