Position                            : Quality Document Control Specialist - Required EDMS, Master Control Exp

Location                           : Vernon Hills, IL

Duration                          : 6 Months

Total Hours/week            : 40.00

1^st Shift

Client                               : Medical Devices Company

Job Category                   : Quality

Level of Experience        : Entry Level or Mid-Level

Employment Type           : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

MasterControl experience is highly preferred. Remote work is possible.

Job Description:

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.

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.