Globus Medical

DocumentControlSpecialist

Audubon, Pennsylvania, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Entry candidates.

The Brief

“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.

Problems you'll solve

Troubleshoots and fixing any and all AX issues; critical thinking skills

Eligibility Requirements

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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