Quality Inspector II

General Atomics; Poway (CA); On-site; USD 45,000 - 67,000; Full time

Job summary

Diazyme Laboratories, Inc., a cGMP and ISO 13485 certified medical device manufacturer, seeks a Quality Inspector in Poway, CA to join the Quality team. You will inspect raw materials, components and finished goods, maintain records, and support routine testing and calibration activities in a compliant lab/warehouse setting.

The role requires reading drawings, basic math, and the ability to work independently or in a team, with potential for extended hours.

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.
• Ability to communicate and interface effectively with all levels of employees and to interpret routine information.

Responsibilities

• Inspects raw material parts, components, labels, sub-assemblies and finished goods to ensure compliance with quality specifications using SOPs.
• May assist with incoming material or equipment testing 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.
• Observes all laws and regulations and works safely according to procedures.

Skills

Reading drawings

Mathematical computations

Communication

Teamwork

Microsoft Office

Independent work

Education

High school diploma or equivalent

2+ years progressive inspection experience

Job description

58538BR

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

General Atomics is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, religious creed, ancestry, gender, pregnancy, sex, sexual orientation, transitioning status, gender identity, gender expression, national origin, age, genetic information, military and veteran status, marital status, medical condition, mental disability, physical disability, or any other basis protected by local, state, or federal law. In accordance with applicable federal law, General Atomics takes affirmative action to employ and advance the employment of qualified protected veterans and individuals with disabilities. We also prohibit compensation discrimination under all applicable laws. U.S. Citizenship is required for certain positions. To learn more, please review the EEOC’s "Know Your Rights: Workplace Discrimination is Illegal" poster.