What are the responsibilities and job description for the Document Control Specialist - 238067 position at Medix™?
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.
