Quality Control Associate

Quality         ·      Poway, California     ·       Full time

Date posted: 10/25/2022
Job ID: 38690BR
Company: Diazyme
Experience Level: Entry-Level (0-2 years)
Job Title: Quality Control Associate
City:  Poway
State: California
Full-Time/Part-Time: Full-Time Hourly

Job Summary

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.

We currently have an exciting opportunity for a Quality Inspector in our affiliate Diazyme Laboratories Inc. located in Poway, CA. 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 engineering drawings and raw material specifications. Maintains records, processes, and updates confidential and sensitive electronic and hard copy reports, records and statistics.

Duties & 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.
• Sets up and calibrates measuring and test equipment and schedules service and repair of equipment. May maintain calibration computer databases.
• 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 engineering 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
• Familiarity with the use of 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 1348 quality assurance program requirements, are desirable

Travel Percentage Required 0 – 25
Relocation Assistance Provided Not Provided
US Citizenship Required? No
Clearance Required? No

Please click here to apply.