Document Control Specialist

Lead Document Control Specialist- Quality or Regulatory Affairs

Location: Portage, MI (On-site)

Duration: 18-month contract (to start)

Position Summary

The Lead Document Control Specialist is responsible for the control, review, release, archiving, storage, and obsolescence of quality documentation for site operations, including procedures and specifications. This role also supports periodic reviews, CIDTs, and post-release activities to ensure compliance with applicable regulatory requirements and quality standards.

Essential Duties & Responsibilities

• Manage all activities related to document routing, distribution, and release to ensure availability of current, effective documentation
• Ensure timely archiving and secure storage of applicable documentation
• Retrieve documents and records as needed to support investigations, audits, and reports
• Serve as the Subject Matter Expert (SME) for document control processes and activities
• Develop and deliver training, coaching, and support on PLM system usage and documentation/change processes
• Lead and support quality system improvement initiatives and participate in cross-functional teams
• Act as the primary point of contact for process owners during implementation of external documents into the local QMS, including the CIDT process
• Maintain, input, and report on quality KPIs, including periodic reviews, CIDT metrics, supplier notifications, and change activity RFTs for trending and management review
• Assist with issue investigations, corrective actions, rework, problem-solving, and process improvements
• Support regulatory and company audit activities as required
• Serve as backup to the Change Specialist

Education & Special Training

• Bachelor’s degree required or equivalent level of education
• Bachelor’s degree preferred (U.S. & Ireland)
• EQF Level 6 or equivalent (EU)

Qualifications & Experience

• Minimum of 4 years in a Quality or Regulatory Affairs environment, including at least 2 years in Document Control or a related function
• OR
• 0–1 year of Quality/Regulatory Affairs experience with a Bachelor’s degree or equivalent
• Ability to gain and apply knowledge of U.S. and international medical device regulations (ISO 13485, MDSAP, 21 CFR Part 820 preferred)
• Understanding of supporting Quality Systems (e.g., audits, management review, quality planning)
• Strong organizational skills with the ability to prioritize tasks and manage competing deadlines
• Effective communication skills; able to collaborate, share information, and participate in team discussions
• High proficiency with PC-based systems and document management tools
• Ability to analyze data and identify basic actions from trends
• Fluent in written and spoken English (B2 level or higher)