58538BR Quality Inspector Diazyme Poway California Job Summary Diazyme laboratories, Inc., is a cGMP and

ISO 13485

certified medical device manufacturer (www.diazyme.com). Diazyme uses its proprietary enzyme technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. The products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes. We currently have an exciting opportunity for a Quality Inspector located in Poway, CA (San Diego area). This person will join a multidisciplinary Quality team focusing on diagnostic product quality assurance. Under general supervision, this position is responsible for inspecting raw material parts, labels, sub-assemblies, equipment, and finished goods to ensure compliance with company specifications, and quality requirements. Sets up, operates, inspects, , parts, subassemblies and finished goods for conformance to specifications. Maintains records, processes, and updates confidential and sensitive electronic and hard copy reports, records and statistics.

DUTIES AND RESPONSIBILITIES

Inspects raw material parts, components, labels, sub-assemblies and finished goods to ensure compliance with quality specifications using standard operating procedures (SOPs). Maintains quality documentation. May assist with incoming material or equipment testing, as necessary, to verify compliance with requirements. May monitor and verify quality in accordance with statistical process or other control procedures. Works in a lab or warehouse environment requiring long periods of standing, walking, bending and lifting up to 50lbs. Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a high school diploma or equivalent and two or more years of progressive experience in biotechnology, chemical, electrical, mechanical, electromechanical or metrology inspection and calibration. Must be customer focused and possess: the ability to read and understand drawings and raw material specifications, and perform basic mathematical computations; the ability to communicate and interface effectively with all levels of employees; the ability to interpret routine information and respond to routine issues; the ability to maintain the confidentiality of sensitive information; and familiarity with the use of Microsoft office software. The ability to work independently or in a team environment is essential as is the ability to work extended hours as required. Experience with

FDA, ISO 9001, ISO

13485, quality assurance program requirements, are desirable. Job Category Quality Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 45,000 Pay Range High 67,125 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? No Clearance Required? No