Final Release Specialist

Position Summary

This position is a support role with a focus on Final Release Documentation Review. 

Principal Responsibilities

•    Providing Quality Assurance support to the Device and Extrusion manufacturing areas by conducting full documentation reviews of Device History Records (DHRs)
•    Completing transactions in the SAP system, including the generation of Certificates of Conformance (COCs)
•    Generating Certificates of Analysis (COAs) and inspection reports
•    Verifying packaging and labels
•    Entering data into computer databases including SAP system
•    Generating and providing DHR Error Rate reports
•    Scanning of documents into an electronic file storage database
•    Filing, labeling, and staging of documents

Education / Experience Requirements

•    High School Education/GED or equivalent work experience
•    Strong knowledge of cGMP/GDP required
•    Minimum of 2 years of working in a Medical Device manufacturing environment in a Quality role required

Specialized Skills / Other Requirements

•    Basic computer and math skills, knowledgeable in Microsoft Office required
•    Strong attention to detail; ability to read and interpret prints, procedures and specifications and demonstrate the ability to be thorough and accurate
•    Familiarity with ISO 13485 preferred
•    Excellent verbal and written communication skills
•    Must work well in a team environment 
•    Ability to adjust to changing priorities and responsibilities
•    Knowledge of SAP system preferred; ability to learn SAP system required
•    Consistent lifting: 5 - 20 lbs. necessary/ Max = 40 lbs.
•    Able to work over-time if required
•    The hours of this position are typically within those of 1st shift but are dependent upon the needs of Manufacturing (i.e. starting prior to 7:00am and/or ending after 3:00pm).

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