Quality Systems Technician

Quality Systems Technician, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Irving, Texas (In person)

Will support manufacturing and production processes for bloodlines, peritoneal dialysis products, solutions and concentrates, involving assembly, troubleshooting, and/or testing. Will conduct quality associated laboratory tests in support of manufacturing operations and will analyze and record test data to monitor and maintain conformity to company specifications. Will perform duties in alignment with Fresenius' Test Methods (TM), Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). Specific duties will include the following:

• Work within Fresenius standards and product specifications to test and analyze samples, set up and operate laboratory equipment, perform product testing and support testing for line validations, Quality Incentive Programs (QIPs), engineering studies, and stability studies.
• In performing analyses and testing, will work with bill of materials, components, engineering drawings, assembly, layouts, packaging design, connection systems, testing, sterilization, material stability, interaction and compatibility with other systems, biocompatibility, risk management, user requirements, design verification and validation.
• Use, select and maintain testing equipment for Fresenius medical devices and other products;
• Utilize and apply knowledge of Fresenius standards, regulations and product specifications to assess and improve quality of manufactured products.
• Operate, maintain, and repair a wide range of machinery, equipment and tools using in testing and analysis including the Instron Tensile Testing Machine, optical comparators, scales, Uson leak testers, pump machines, etc.
• Calibrate, fine-tune, and adjust laboratory equipment to achieve precise results.
• Execute safety protocols associated with Fresenius' medical device manufacturing and testing lab environments including the proper handling of hazardous materials, the use of personal protective equipment, and emergency response procedures of equipment and machinery.
• Complete documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
• Maintain proper Good Laboratory Practices and techniques for handling laboratory reagents and instrumentation.
• Provide training to new employees and assistance to junior level staff with more complex support tasks that require a higher level of understanding of functions, as directed by immediate supervisor.
• Escalate issues to supervisor for resolution, as deemed necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

Requirements:

Position requires a Bachelor's degree (or an equivalent foreign degree) in Industrial and Systems Engineering, Manufacturing Engineering or a closely related field and 3 years of experience as a Quality Control Technician or Analyst.

Must also have 3 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

• Performing and designing laboratory tests in compliance with Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP);
• Using and maintaining laboratory testing equipment including Atomic Absorption, Autotitrator, FTIR, Autopol and Incubators;
• Operating and maintaining product design machinery including balances/scales, measurement tools, leak testers, tensile, mixing tanks.
• Relevant safety protocols, including the use of Personal Protective Equipment (PPE), chemical hygiene standards, lock-out/tag-out procedures, and hazardous material disposal and working in environments that require gowning and strict adherence to hygiene protocols;
• Recording test data, maintaining lab notebooks, and completing forms; and
• FDA regulations for medical devices (CFR 820). #LI-DNI