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
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Review all changes and in a timely manner with high level of detail
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Contribute to cross-functional improvement initiatives
- Provide input during weekly change board meetings to facilitate change review and closure
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Support the proper organization, filing, archiving, and secure destruction of all controlled documents whether electronic or paper
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Ensure all change requests and documents within the Quality Management System are reviewed by the appropriate department
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Review change orders for accuracy, completeness, and impact to other documents, products, processes, and the PLM or ERP systems
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Review documents for the proper formatting and editing prior to submitting for approval
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Provide Good Documentation Practices guidance to the team as needed
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Support the maintenance of design history files, device master records, and device history records as needed
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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
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Familiarity with GDP and working in the medical device field preferred
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Familiarity with ISO 9000 and/or ISO 13485 preferred
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Systems oriented with solid and demonstrable PLM and/or ERP experience
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Team player who prefers to take a collaborative approach in problem solving
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Organized, detail oriented, and self-directed; able to meet goals and deadlines without constant supervision
EDUCATION: Bachelor’s or comparable experience.
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