Quality Documentation Reviewer

• Improve manufacturing processes and documentation accuracy by eliminating repetitive actions in instructions and validation documents using RAA (Repetitive Action Assessment) and PFMEA (Process Failure Mode and Effect Analysis). • Navigate manufacturing instructions, procedures, and validation documents to identify and eliminate repetitive actions, improving process efficiency. • Maintain documentation accuracy by redlining, assessing site documentation, identifying gaps, Creating product disposition instructions and authoring qualification reports to support product release and compliance with ISO 13485 and FDA regulations. • Assess site documentation against global standards, identifying gaps, and driving alignment with corporate and regulatory requirements. • Maintain equipment listings and defining documentation requirements through validation procedures, supporting successful equipment qualification and ongoing compliance. • Analyze production line performance to identify deviations and opportunities for documentation and process improvement. • Provide technical writing and documentation for quality and manufacturing documents. • Collaborate cross-functionally to ensure regulatory compliance and provide technical writing for quality and manufacturing documents like Disposition Instruction (DI), Qualification Report (QR)