Branch Medical Group · 9 hours ago
Document Control Specialist
Audubon, PA
Full-time
Onsite
Entry Level
2+ years expGlobus Medical is dedicated to improving the quality of life for patients with musculoskeletal disorders. The Document Control Specialist will manage and organize all quality documentation required for compliance, including issuing, maintaining, and auditing documentation, while also coordinating training processes and ensuring adherence to corporate standards.
Health CareManufacturingMedicalMedical Device
Responsibilities
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
Assists in conducting various training classes relating to documentation practices that pertain to Quality on an as-needed basis
Oversees new item creations as well as set up within the system
Creates and updates all BOMs and Routes
Monitors all transactions within AX
Troubleshoots and fixing any and all AX issues that arise, including improvements and functional testing
Updates and maintains Net Dimensions training system
Participates in continuous improvement activities and implements changes for improvement
Keeps supervisor informed of work-related activities and issues related to agreed-upon goals and objectives
Maintains cooperative and friendly attitude with coworkers
Adheres to all company policies, procedures and housekeeping standards
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Qualification
Required
High school diploma or higher with minimum of 2 years progressive work experience, preferably in the medical device industry or other regulated industry
Ability to review documentation for accuracy, perform data entry, scan and file documents
Must be 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
Company
Branch Medical Group
Branch Medical Group is manufactures medical implants and graphic cases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2015-02-25Acquired
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