Bill is $55 depending upon experience
Remote Hybrid preferred
MasterControl experience is highly preferred. Remote work is possible.
Job Description Summary
Summary / Purpose of Position:
This role is responsible for the administration and coordination of the change control, documentation and training systems for BDI Surgery.


Job Description
Essential Duties and Position Responsibilities:
Serve as the Electronic Document Management System (EDMS) and Learning Management System (LMS) administrator (e.g., maintain accurate users, assign passwords and privileges, update training requirements, etc.)
Ensure timely, accurate and efficient preparation and management of documents
Control the numbering, sorting, filing, storing and retrieval of both electronic and hard copy documents
Process changes via the EDMS systems
Provide database navigation and troubleshooting support for the EDMS, LMS system)
Assist managers to ensure required training is assigned and documented
Provide documentation and training compliance metrics as requested
Maintain central device master documentation
Maintain records in accordance with record retention policies.
Interface with internal and external auditors during review of the applicable quality management sub-systems (i.e., those pertaining to documentation, change control, and training)
Continuous improvement of the change control, documentation control, and training systems.
Successful completion of projects assigned by management to support business imperatives.
Other duties as assigned
Qualifications, Knowledge, and Skills Required:

Associate degree preferred, high school diploma or equivalent required.
Excellent verbal and written communication skills.
Strong collaboration across business functions.
Ability to aggressively drive results in multiple projects simultaneously.
Use of Microsoft Office software to generate formal procedures, control logs and databases.
Two years of relevant work experience required, preferably in a regulated medical device or pharmaceutical environment.
Understanding of blueprints, standard operating procedures, and overall documentation systems.