Quality Records Specialist - Finish Line Staffing Services
Somersworth, NH
About the Job
Our client, a medical device manufacturing company, has an immediate opening for a Quality Records Specialist. This role will perform and ensure the product documentation is complete, accurate, and compliant to the ISO 13485 standards and FDA regulations.Responsibilities:
- Proofread, implement, and ensure accuracy, quality, and integrity of all manufacturing documents
- Ensure easy and efficient retrieval of documents
- Ensure that obsolete documentation is removed from distribution and is appropriately archived
- Responsible for execution of all Document Change Orders in support of manufacturing, engineering, and other departments, as necessary in accordance with policies and procedures
- Organize and maintain Design History Files
- Perform label inspection on product labeling
- Enter data into various Microsoft Access databases
- Review and proofread documents for quality control
- Minimum of 3 years of experience in an admin position
- A working knowledge and/or experience in the creation of Adobe PDF control documentation
- Organizational and communication skills enabling accurate and detailed change order processing
- Excellent interpersonal, verbal, and written communication skills
- Ability to interface with a variety of people and be able to work as part of a team
- Exceptional proof reading and quality control skills
- Experience working with an MRP interfacing system
- Experience working in a fast-paced environment as part of a cross-functional team
- Demonstrated track record working with limited direction to produce high quality work
- Proven ability to provide logical, in-depth analysis of a problem or situation
Source : Finish Line Staffing Services