Diazyme, an affiliate of General Atomics, is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Their products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes. Under limited supervision, this position is responsible for performing analysis of raw material, packaging material, in-process material, and finished products according to established procedures to determine conformance to accepted specifications. The role involves conducting tests to maintain and certify test instruments and apparatus for regulatory compliance, monitoring and documenting product quality following approved control procedures, and maintaining, analyzing, and developing various records and reports. The individual may represent the organization to outside customers and vendors and provide direction and guidance to less experienced staff.