Document Control Specialist
4 weeks ago
We are seeking a highly organized and detail-oriented Document Control Specialist to join our quality team at GT Medical Technologies, Inc. As a key member of our team, you will be responsible for managing our document control systems and training programs, ensuring compliance with FDA regulations and ISO 13485 standards.
Key Responsibilities:
- Manage document control systems, including creation, storage, organization, and retrieval of controlled documentation
- Develop and implement training programs for employees on document control procedures and systems
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
- Monitor and report on quality metrics related to document control and training
- Implement best practices and innovative solutions to enhance efficiency and effectiveness
Requirements:
- Associate degree in technical or business-related field; Bachelor's degree preferred
- 2 years' experience in manufacturing/operations, with a minimum of 2 years in medical device manufacturing and quality assurance
- Working knowledge of 21CFR Part 820 and ISO 13485:2016 regulations and QM Systems
- Strong organizational skills and attention to detail
- Proficiency in Microsoft Office Suite and document control software
- Ability to work independently and as part of a team
Physical Demands/Working Conditions:
- Works in office space, supply room, laboratory, and/or clean room environments
- Frequent exposure to hazardous materials requiring appropriate PPE and precautions
- Requires frequent finite hand/eye coordination
- Largely a stationary role with some moving from place to place
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Document Control Specialist
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