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.
Position Overview: 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.
Responsibilities:
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
Qualifications and Skills:
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
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