We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.
We are seeking a Document Control Specialist to support our Quality Team. The Document Control Specialist is responsible for managing the release, maintenance, retrieval, disposition and retention of controlled documents in support of medical device manufacturing and operations for multiple clients. This position will report to the Quality Manager of Experien Group.
MAJOR DUTIES OF POSITION:
· Generates and processes document change orders to release documents (e.g., Standard Operating Procedures, forms, components, part numbers, etc.) into each client’s Quality Management System
· Maintains clients’ controlled document files to ensure only current released documents are available for use
· Maintains the control of records including CAPAs, NCMRs, Design Control, Risk Management files, etc.
· Assists in updating clients’ Standard Operating Procedures and other Quality Management System procedures
· Manages clients’ training activities including sending out training notifications and maintaining individuals’ training records
· Assists in implementing and maintaining clients’ Electronic Document Management Systems, as applicable
· Scanning, filing and maintenance of all types of Quality System documents and records
· Maintain Document Control and Quality System-related document retention, databases and logs
· Assist with other Quality System related duties, as assigned
KNOWLEDGE AND SKILL REQUIREMENTS:
· College degree preferred
· Minimum of two years experience with Document Control in a regulated environment
· Proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
· Must be able to work independently with minimal supervision
· Must be organized and have strong attention to detail
· Excellent communication and time management skills required
· Ability to learn quickly and prioritize multiple tasks in a fast paced and dynamic environment
· Ability to work on multiple projects for multiple clients at the same time
· Knowledge of ISO 13485:2016 and 21 CFR 820 requirements preferred
· Knowledge of Electronic Document Management Systems preferred
- Medical, Dental and Vision Benefits
- 18 Days of Paid Time-Off (PTO)
- 11 Paid Holidays
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.