Production Builder I

Job description

General Summary Under supervision, the Production Builder I performs moderately complex assembly. Performs data recording and product testing. Specific Duties and Responsibilities: Assemble medical devices according to Federal QSR, ISO 13485, lot history records, manufacturing instructions, standard operating procedures, and safety policies. * Perform in-process inspection of components and assemblies to verify quality conformance. * Record information on lot history records and perform component accountabilities. * Set-up and operate manufacturing equipment. * Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program. * Clean supplies and manufacturing equipment and work areas. * Reports causes of process and/or documentation issues and assists in resolution. * Responsible for completion of personal training records. Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applica...