About this role
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.