Quality Control Technician

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.

Summary
Under general supervision, this position is responsible for performing the analysis of raw material, packaging material, in-process material, and finished products according to established procedures to determine conformance to accepted specifications for the product. The role includes performing a variety of tests to aid in the maintenance and certification of test instruments and apparatus to ensure compliance with regulatory requirements. Additionally, this position monitors, verifies, and documents the quality of products in accordance with statistical, regulatory, company, or other approved control procedures.

Duties & Responsibilities

• Perform analysis of raw material, packaging material, in-process material, and finished products according to established procedures.
• Prepare various reagents, solutions, instruments, and apparatus to support testing activities.
• Clean, test, and prepare various instruments and apparatus to ensure continued certification and compliance with regulatory requirements.
• Develop and analyze confidential and sensitive electronic and/or hard copy records, reports, and files.
• Participate in the development of test protocols, quality control documentation, and record keeping.
• Prepare reports and present data at team meetings and management reviews.
• Complete and review various good manufacturing practices, safety, and regulatory required forms.
• Ensure all appropriate documentation is updated, reported, and filed.
• Provide training, direction, and guidance to less experienced staff as needed.
• Observe all laws, regulations, and other applicable obligations while conducting business on behalf of the Company.
• Work safely in accordance with established operating procedures and practices.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.




Job Qualifications:

• This position typically requires an associate’s degree or trade school certification along with one or more years of experience working as a quality technician in a manufacturing environment. Equivalent experience as a quality technician may be substituted in lieu of formal education.

• General understanding of quality procedures in a manufacturing environment.

• Knowledge of quality concepts and principles, including the ability to read and understand engineering drawings and specifications.

• Ability to identify and interpret data effectively.

• Strong interpersonal, verbal, and written communication skills to explain general information at all levels of the organization.

• Organizational skills to maintain workflow within the unit.

• Ability to establish priorities and manage tasks efficiently.

• Ability to maintain confidentiality of sensitive information.

• General knowledge of computer operations, applications, word processing, and spreadsheets.

• Ability to work both independently and in a team environment.

• Willingness to work extended hours as required.

Salary:$48,160 - $71,598