Job Description

• 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