Document Control Specialist & Training Coordinator

About the role

Manage the document control process for new and revised procedures within the QMS. Maintain the training matrix and ensure training assignments are distributed, completed, and maintained in accordance with regulatory requirements. Partner with Quality, Regulatory, and other cross-functional departments to support timely document reviews, approvals, and training completion. Identify and lead improvements to QMS, document control, and training processes and systems to increase efficiency and compliance.

Responsibilities

• Review and obtain approval of quality system documentation (quality manual, procedures, work instructions, forms, corporate operating procedures, and policies). Develop and maintain various quality system documentation and documentation files, both electronic and hardcopy.
• Administer document numbering, revision history, and approval workflows for controlled documents within the QMS, in accordance with ISO 13485, 21 CFR 820, and EU MDR requirements.
• Assist in preparation of regulatory submissions to national and international government agencies, e.g., US FDA and Health Canada.
• Maintain documentation files including Quality System documentation, Departmental files, archived files, and reference material files in both hardcopy and electronic formats.
• Support the change control process for revisions to controlled documents; track change requests through review, approval, and implementation to ensure timely closure.
• Conduct periodic reviews and audits of controlled documents to verify accuracy, completeness, and continued regulatory compliance; support document control metrics and reporting.
• Identify, recommend, and lead improvements to document control and QMS processes and systems, such as streamlining review/approval workflows or enhancing the eQMS platform.
• Manage the corporate training matrix and revise as needed. Manage distribution of training material, maintain training files, and ensure compliance with regulatory requirements.
• Track training assignment completion, generate compliance metrics and reports for management, and follow up on past-due assignments.
• Partner with department managers to identify training needs arising from procedure revisions, new hires, and audit findings.
• Assist in on-boarding of new hires.
• Assist management with internal and external audits.
• Assist in the development and distribution of the annual management review.
• Perform special projects as needed.

Requirements

• Bachelor’s degree in a related field or comparable experience working in the medical device industry, Quality Assurance, Regulatory Affairs, Compliance, or Development.
• Ability to learn and understand technical concepts as well as national and international government procedures, practices, regulations, and guidelines (e.g., US FDA, EU MDR, and Health Canada).
• Excellent technical writing skills.
• Proficient in Adobe Acrobat, Microsoft Office (Word, Excel, PowerPoint, Access), and SharePoint.
• Experience with an electronic Quality Management System (eQMS) or document control software preferred.
• Experience developing, implementing, and/or maintaining a Quality Management System (QMS), with working knowledge of ISO 13485, 21 CFR 820, and EU MDR document control requirements strongly preferred.
• Experience coordinating or administering corporate training programs, including use of a Learning Management System (LMS), preferred.

Skills

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit.
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Benefits

• Medical, dental, and vision coverage
• Company-paid life and disability insurance
• 401(k) match
• Generous paid personal leave (PPL)
• 12 paid holidays
• Education reimbursement