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

Requirements:

• 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