Globus Medical
DocumentControlSpecialist
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“Document Control Specialist at Globus Medical. Skills: Document Control, Quality Documentation Management, Regulatory Compliance. Manage and organize all quality documentation. Issue Quality System documents”
What You'll Achieve.
improve the quality of life of patients; patients can resume their lives as quickly as possible; deliver innovations; transform clinical insights into tangible solutions; improve the techniques and outcomes of surgery; deliver solutions that will improve the lives of our customers and patients
Industry & Context.
Troubleshoots and fixing any and all AX issues; critical thinking skills
Required to climb or and stoop, kneel, crouch or crawl, Required to regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds, Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
What They're Looking For.
Must Have
minimum of 2 years progressive work experience, Ability to review documentation for accuracy, perform data entry, scan and file documents, Knowledgeable with Microsoft Word and Excel programs, Experience utilizing planning software, Experience with training, developing and reviewing of planning software processes and procedures from a functional perspective, Good organizational, typing, analytical, and critical thinking skills, Good communication and writing skills
Nice to Have
preferably in the medical device industry or other regulated industry
What You'll Do.
Manage and organize all quality documentation
Issue Quality System documents
Coordinate the training process
Issue device master record documents
Process Document Change Orders (DCOs)
Maintain the distribution of controlled copy documents
Organize and communicate status of work
Ensure documentation is complete
Assign and track new part numbers
Perform database searches
Perform data analysis
Use manufacturing business systems
Assist in conducting training classes
Oversee new item creations
Set up within the system
Create and update all BOMs
Create and update all Routes
Monitor all transactions within AX
Troubleshoot and fix AX issues
Update and maintain Net Dimensions training system
Participate in continuous improvement activities
Implement changes for improvement
Keep supervisor informed of work
Maintain cooperative and friendly attitude
Adhere to all company policies
Adhere to housekeeping standards
Adhere to Code of Conduct
Ensure Compliance with governmental laws
Maintain knowledge of compliance
Represent the company professionally
Uphold ethical business practices
How You'll Work.
Team & Collaboration
Communicate status of work to management and other personnel; Work with other employees; Support each other; Make each other stronger
Communication Scope
Good communication skills; Good writing skills
Full Job Description
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. ** _Position Summary:_** The primary function will be to manage and organize all quality documentation that is required by Globus Medical, Inc. and other regulatory agencies. This will include issuing, maintaining, controlling, and auditing documentation that is required for quality and cGMP compliance. The primary responsibilities of the position include the following: **_Essential Functions:_** * Issues Quality System documents and coordinate the training process * Issues device master record documents (manufacturing process specifications, inspection plans, routers, etc.) and other technical documents during the development, release, and maintenance phases of product realization * Processes Document Change Orders (DCOs) to implement all controlled documentation and maintain the distribution of controlled copy documents * Organizes and communicates status of work to management and other personnel as required and keeps them informed of objectives and progress * Ensures documentation is complete, properly formatted and meets corporate standards * Assists in assigning and tracking new part numbers through the development cycle * Performs database searches, data analysis, and reporting to assist design engineers on product development * Uses multiple manufacturing business systems, spreadsheets, graphs, word processors and product information management systems in order to facilitate document release, change, and data storage & retrieval processes *
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