Document Control Specialist III

Job description

Job Summary: A Document Control Specialist in the medical device industry manages, organizes, and maintains controlled documents (SOPs, specifications, drawings) to ensure compliance with FDA 21 CFR Part 820.40, ISO 13485, and GMP standards. This role supports cross-functional teams by ensuring accurate lifecycle documentation, manage change requests, proper revision control, and timely distribution of quality and regulatory documents. This position leads projects related Document Control. Responsibilities (Specific tasks, duties, essential functions of the job) - Lead and oversee document control operations across multiple functions or sites. Participate in document change requests, updating, approving, and distributing documents while ensuring only the current versions are in use. - Act as the document control SME for FDA, ISO 13485, MDSAP, and global regulatory inspections. - Own and maintain document control procedures, templates, and governance models. - Partner with Quality, Regulatory, R&D, Manufacturing, and Post Market teams to ensure document alignment. - Manage complex document change initiatives, including system updates in document control system (MasterControl) and ER...