Document Control Specialist

Matlen Silver; Portage (MI); On-site; USD 57,859 - 59,236; Full time

Job summary

A quality management consultancy firm is seeking a Lead Document Control Specialist in Portage, MI, for an 18-month contract. The role involves overseeing document control processes and ensuring compliance with regulatory requirements. Candidates must have a Bachelor's degree and a minimum of 4 years in Quality or Regulatory Affairs. Strong organizational and communication skills are essential for this position, which is critical in maintaining quality documentation within medical equipment manufacturing.

Qualifications

• Minimum of 4 years in a Quality or Regulatory Affairs environment.
• Able to gain knowledge of U.S. and international medical device regulations.
• Fluent in written and spoken English (B2 level or higher).

Responsibilities

• Manage all activities related to document routing and release.
• Ensure archiving and secure storage of documentation.
• Serve as the Subject Matter Expert (SME) for document control.

Skills

Organization skills

Effective communication

Data analysis

Education

Bachelor’s degree or equivalent

Tools

Document management tools

Job description

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Base pay range

$42.00/hr - $43.00/hr

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.

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)

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Writing/Editing and Quality Assurance

Industries

Medical Equipment Manufacturing

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