Document Control Specialist

Lead Document Controller

18-month contract

We are seeking a Lead Document Controller to manage the control, review, release, archiving, and obsolescence of documentation, including procedures and specifications. This role supports periodic reviews, CIDTs, and post‑release activities to ensure compliance with applicable regulatory requirements and standards.

• Manage document routing, distribution, release, archiving, and retrieval
• Ensure availability of current, effective documentation
• Act as a subject matter expert for document control processes
• Support PLM system use, documentation, and change processes
• Lead quality system improvement initiatives and collaborate cross‑functionally
• Maintain and report quality KPIs, including periodic reviews and change activities
• Support investigations, audits, and regulatory activities
• Serve as backup to the Change Specialist

• Bachelor’s degree (or working toward) or equivalent
• Experience in Quality/Regulatory Affairs with document control exposure
• Understanding of medical device regulations (ISO 13485, MDSAP, CFR Part 820 desired)
• Strong communication, collaboration, and data management skills
• High PC proficiency
• Fluent in written and spoken English (B2 level)

Associate

Contract

Quality Assurance and Other

Industries:
Medical Equipment Manufacturing and Pharmaceutical Manufacturing