Documentation Specialist Globus Medical
THIS JOB HAS EXPIRED Description
The primary function of the Documentation Specialist 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.
Perform engineering documentation during the design, release and maintenance phases of products.
Coordinating, writing, and releasing Document Change Orders (DCOs) with inputs from other functional areas.
Communicate the impact of engineering changes across functional areas.
Ensures documentation is complete, properly formatted and meets corporate standards.
Assist Director-QA 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 the engineering release, change, and data storage & retrieval processes.
Organize and Lead Quarterly plant wide documentation audit. Manage follow-up list from the audit.
Assist in conducting various training classes relating to documentation practices that pertain to Quality on an as needed basis.
Assist with the day-to-day functions of the Quality area.
Other duties and responsibilities as assigned.
5 Years of GMP/FDA experience
Strong interpersonal and communications skills; ability to develop and express ideas.
Responsiveness to changing business conditions and customer needs.
Ability to multi-task in a fast-paced environment.
Knowledge of Pro/E preferred.
Strong computer skills in Microsoft Office Systems.
Knowledge in ISO, GMP and FDA practices.
||Valley Forge Business Center |
2560 General Armistead Avenue
Audubon, PA 19403
THIS JOB HAS EXPIRED