Description: We are seeking a detail-oriented Document Control Specialist to join our team. The successful candidate will manage and maintain the document control system, ensuring accurate documentation and compliance with regulatory requirements for medical device manufacturing.
Responsibilities:
Manage the document control system, including the creation, revision, and archiving of documents.
Ensure documents are reviewed, approved, and distributed in compliance with FDA, ISO 13485, and other regulatory standards.
Maintain accurate records of controlled documents, including SOPs, work instructions, validation protocols, and technical files.
Coordinate document changes, revisions, and version control, ensuring timely updates across all departments.
Support audits by preparing documentation and ensuring all records are accurate and up to date.
Collaborate with cross-functional teams to ensure consistent and efficient documentation practices.
Train staff on document control procedures and usage of document management systems.
Assist in the development and improvement of document control processes and systems.
Skills:
Propel
Strong organizational skills with a keen eye for detail.
Proficiency in document management software and Microsoft Office Suite.
Familiarity with FDA QSR, ISO 13485, and other regulatory requirements for medical devices.
Excellent communication and collaboration skills.
Ability to handle multiple tasks and prioritize effectively in a fast-paced environment.
Requirements:
Associate's or Bachelor's degree in a related field preferred.
Minimum of 3 years of experience in document control, preferably within the medical device or regulated industry.
Experience with electronic document management systems (EDMS).
Knowledge of regulatory requirements and quality standards (FDA, ISO 13485).
Certification in Document Control (e.g., CDCP) is a plus.