Document Control Specialist

Are you highly organized, detail-oriented, and passionate about compliance? Our client in the medical manufacturing industry is seeking a Document Control Specialist to manage and maintain critical documentation supporting design, development, manufacturing, and regulatory compliance. This is an excellent opportunity to join a fast-paced, regulated environment and make an impact on quality and compliance processes. This direct hire role pays $70k-$80k based on experience and competitive benefits, plus bonus incentives.

Key Responsibilities

• Create, review, and maintain controlled documents.
• Manage document workflows: logging, distributing, tracking revisions, and obsolescence.
• Ensure proper formatting, version control, and accessibility for internal stakeholders.
• Coordinate document reviews and approval workflows with authors and approvers.
• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other regulatory standards.
• Prepare documentation for audits and inspections; assist with auditor queries.
• Provide training on document control procedures and Good Documentation Practices (GDP).
• Identify and implement process improvements for document control systems.

Qualifications

• Bachelor’s degree in a science-related field preferred.
• 2 years of experience in document control or quality management systems (QMS), ideally in the medical device industry.
• Strong understanding of document management systems, version control, and regulatory documentation requirements.
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485.
• Excellent organizational and communication skills.
• Ability to manage multiple tasks independently in a fast-paced environment.
• Certifications such as Certified Quality Auditor (CQA) or Certified Document Control Specialist (CDCS) are a plus.