Document Control Administrator

Company Overview

Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.

This Document Control Administrator provides support our document control processes as well as other related quality systems. This role will report to the QMS Manager and contributes as a critical facilitator between manufacturing, engineering, and project teams.

• Support change control administration, part number management, BOMs and BOM structure, and applying revision control within the Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems
• Review all changes and in a timely manner with high level of detail
• Contribute to cross-functional improvement initiatives
• Provide input during weekly change board meetings to facilitate change review and closure
• Support the proper organization, filing, archiving, and secure destruction of all controlled documents whether electronic or paper
• Ensure all change requests and documents within the Quality Management System are reviewed by the appropriate department
• Review change orders for accuracy, completeness, and impact to other documents, products, processes, and the PLM or ERP systems
• Review documents for the proper formatting and editing prior to submitting for approval
• Provide Good Documentation Practices guidance to the team as needed
• Support the maintenance of design history files, device master records, and device history records as needed
• Proactively interface with internal and external customers to convey requirements, resolve issues, fulfill documentation requests, and otherwise facilitate the change process

• Experience working in a manufacturing company required
• Familiarity with GDP and working in the medical device field preferred
• Familiarity with ISO 9000 and/or ISO 13485 preferred
• Systems oriented with solid and demonstrable PLM and/or ERP experience
• Team player who prefers to take a collaborative approach in problem solving
• Organized, detail oriented, and self-directed; able to meet goals and deadlines without constant supervision

Bachelor’s or comparable experience.