Document Control Specialist

The Document Control Specialist is responsible for managing and maintaining documentation in compliance with FDA regulations, ISO 13485 requirements, and company procedures. This role ensures that controlled documents, records, and engineering changes are accurately reviewed, approved, distributed, and archived throughout the product lifecycle.

Key Responsibilities:

• Maintain and control documents, including procedures, work instructions, specifications, and records.
• Administer document change requests and engineering change orders (ECOs).
• Ensure documentation complies with FDA 21 CFR Part 820, ISO 13485, and internal quality standards.
• Support audits by providing accurate and readily accessible records.
• Manage document training assignments and track completion.
• Maintain electronic document management systems (eDMS) and ensure data integrity.
• Collaborate with Quality, Regulatory Affairs, Engineering, and Manufacturing teams to support product development and quality initiatives.

Qualifications:

• Bachelor's degree preferred.
• 5+ years of document control experience, preferably in the medical device, pharmaceutical, or regulated manufacturing industry.
• Knowledge of FDA regulations, ISO 13485, and electronic document management systems.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.