Medical Documentation Specialist
Randstad Sourceright, in collaboration with Bose Corporation, is seeking a Medical Device Document Control Specialist to join the team! We are looking for someone with previous medical device documentation control experience where it will be important to have the knowledge and expertise to maintain the system to keep compliance with the applicable FDA compliance.
- Assist in Administering the Document Control System
- Maintain the system to keep compliance with applicable FDA compliance
- Partner with department managers to ensure all employees understand the system
- Guide Subject Matter Experts in writing and revising documentation required by the Quality Management System.
- Self-starter, capable of working well both independently and in teams
- Detail-oriented and comfortable communicating all issues clearly to the supervisor.
- Ensure documents are routed, reviewed, approved and obsoleted as required by procedures
- Generate and monitor metrics for report out in Management Review and use these metrics to address improvement opportunities.
- Major participant in implementing an electronic document control system combined with a paper system
- Administer Training System, which includes:
o Partner with department managers to develop training criteria for all positions.
o Ensure that training is carried out as scheduled and that all training gaps are closed
o Major participant developing and implementing training tracking system
- Participate in other QMS efforts such as CAPA, Non conformances, internal audits, change management, customer audits, etc. and assist in maintaining the documentation
- Perform other duties as assigned.
Working hours: 8:00 AM - 5:00 PM
--Experience with QMS databases
--Ability to manage numerous priorities and activities in parallel
--Ability to review current processes and implement productivity and compliance improvements.
--Strong people skills to be able to deal with various personalities and levels within and outside of the organization.
--Excellent verbal and written communication skills; ability to write reports or instruction manuals required.
--Excellent organizational skills and be detail oriented.
This is a contract opportunity where a bachelor's degree is preferred.
We are looking for someone with previous medical device documentation control experience where it will be important to have the knowledge and expertise to maintain the system to keep compliance with the applicable FDA compliance.
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