Lead Specialist, Document Control

Base pay range

$40.00/hr - $43.00/hr

We are seeking an experienced Lead Document Control Specialist to support quality and regulatory documentation activities at the site level. This role is responsible for the control, review, release, archiving, and obsolescence of documentation—including procedures and specifications—while ensuring compliance with applicable regulatory requirements and quality standards.

The Lead Document Controller will also support periodic reviews, CIDTs, and post-release activities, acting as a subject matter expert and key point of contact across cross‑functional teams.

• Manage all document control activities, including routing, distribution, and release, ensuring the most current documents are available for use
• Ensure timely archiving and secure storage of controlled documentation
• Retrieve documentation to support investigations, audits, and reporting needs
• Serve as a Subject Matter Expert (SME) for document control processes and systems
• Train, coach, and support teams on PLM system navigation and documentation/change control processes
• Lead and contribute to continuous improvement initiatives within the Quality Systems team
• Act as the primary contact for process owners during implementation of external documents into the local QMS (including CIDT processes)
• Track, report, and maintain quality KPIs (e.g., periodic reviews, CIDT, supplier notifications, change activity RFT)
• Support issue investigations, corrective actions, rework, and process improvement efforts
• Assist with internal and external regulatory audits as needed
• Serve as backup to the Change Specialist when required

• Currently working toward a Bachelor’s degree or equivalent (required)
• Bachelor’s degree (Preferred – U.S. & Ireland)
• EQF Level 6 or equivalent (EU)

• 4+ years in a Quality or Regulatory Affairs environment, including 2+ years in Document Control or related functions
• Bachelor’s degree or equivalent
• Familiarity or ability to gain knowledge of Medical Device Regulations (ISO 13485, MDSAP, 21 CFR Part 820 preferred)
• Understanding of Quality Systems (audits, management review, quality planning)
• Strong communication skills with the ability to collaborate across virtual and cross‑functional teams
• Detail‑oriented with the ability to identify issues, prioritize tasks, and contribute to continuous improvement
• Strong data and documentation management skills
• High proficiency in PC and document management systems
• Fluent in written and spoken English (B2 level)

• Mid‑Senior level

• Contract

• Administrative and Manufacturing

• Staffing and Recruiting and Medical Equipment Manufacturing