Document Control Specialist - 238067 - Medix™ : Job Details

Looking for a Document Control Specialist with prior experience in the medical device industry. Looking to get someone started ASAP or as soon as the end of January. This is a contract position roughly 4 to 6 months. It is a great opportunity to get your foot in the door with the organization.

Role Overview:

The R&D Document Specialist is essential in managing products through various stages of the Product Lifecycle Management (PLM) process for R&D. This position focuses on the preparation, evaluation, and acceleration of R&D documentation within Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) platforms. Acting as the Subject Matter Expert (SME) in PLM and document control, the specialist ensures that all R&D documents are thorough, accurate, and compliant.

Key Responsibilities:

• Serve as the R&D Subject Matter Expert (SME) in document change control within PLM systems.
• Collaborate with R&D teams to guide and facilitate Engineering Change Orders (ECOs) and Change Orders (COs) through preparation, routing, approval, and release within QMS/ERP systems.
• Support the development of New Product Development (NPD) documentation in QMS/ERP systems for R&D initiatives.
• Identify and implement document control best practices to drive continuous improvement in R&D NPD projects.
• Create comprehensive reports and queries related to ECO/CO accuracy, approvals, and process efficiency in QMS.
• Monitor and assess process effectiveness, analyze the impact of changes, and recommend improvements for PLM document control systems.
• Manage and ensure the accuracy of Global Trade Identification Number (GTIN) data within relevant systems.
• Contribute to problem-solving activities, metric reporting, and various cross-functional projects as assigned.
• Deliver high-level customer service and support to key cross-functional teams.
• Lead or participate in special projects as needed.
• Provide audit and training support as required.

Note: Approximately 75% of the role involves direct R&D-related activities.

Qualifications and Experience:

• Bachelor's or technical degree in a related field (preferred).
• Minimum of 3 years of experience in the design and development of medical devices.
• Experience in document control using PLM and ERP platforms (Oracle Agile/SAP preferred).
• Proficiency in Microsoft Word, Excel, Outlook, and Adobe Acrobat.