Document Coordinator

About the Role

We are seeking a highly organized and detail-oriented Document Coordinator to support our existing team in maintaining accurate documentation for ongoing compliance and accessibility of the Quality Management System. This role plays a critical part in maintaining the integrity of our compliance certifications by ensuring quality standards, work instructions, and training materials are consistently updated and aligned with regulatory and internal requirements. Reporting to the Program Manager, U.S. Manufacturing, the Document Coordinator will collaborate closely with the Training team to support initiatives that enhance quality performance and readiness across the organization. 

📍 Location: This is a full-time, on-site position at our manufacturing facility in Obetz, OH. The role requires workingfive days per week on-site. Because this position involves regular interaction on the production floor, the selected candidate will be required to undergo pre-employment drug testing in accordance with company policies and applicable law.

Responsibilities:

• Document Control: Maintain, update, and archive controlled documents including standard operating procedures (SOPs), work instructions, quality standards, forms, and records in accordance with ISO 13485 Certification requirements and internal procedures.
• Quality System Management: Ensure documentation reflects current practices and supports compliance with ISO 13485 and other relevant regulatory standards. Participate in internal audits and assist in audit readiness activities.
• Collaboration with Training Team: Coordinate with the Training Coordinators to ensure revised documents are effectively communicated and training materials are kept current. Support document changes and training rollouts.
• Process Improvement: Assist with all quality initiatives and continuous process improvements by providing documentation support and standardizing documentation practices across departments.
• Change Management: Process and track document change requests, working with subject matter experts (SMEs) to ensure accurate revisions and timely implementation.
• Version Control and Recordkeeping: Maintain accurate records of document history and approvals. Ensure obsolete documents are properly removed and archived.

Basic Qualifications: 

• High school diploma or GED required
• 2+ years of experience in document control, quality systems, or administrative support in a regulated manufacturing environment (medical device, pharmaceutical, etc.)
• Expert-level experience with Microsoft Office Suite/Google Suite and electronic quality management systems (EQMS) i.e. Greenlight Guru or something similar
• Strong attention to detail, organization, and time management skills
• Excellent written and verbal communication skills
• Ability to work independently as well as collaboratively in a cross-functional team environment
  
  

Preferred Qualifications:

• Associate’s or Bachelor’s degree in a technical or quality-related field strongly preferred
• Familiarity with ISO 13485 or similar quality management systems is strongly preferred
• Experience with QMS software is a plus

Compensation

In addition to other forms of compensation like perks and benefits, the estimated range for this role is $61,000 - $77,000. The final offer will be determined based on permissible, non-discriminatory factors such as skill set, experience, geographical location, market conditions, and other organizational needs. The Company reserves the right to change, modify, or revisit the salary range for various reasons including business needs.




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