Quality System Specialist II

Location: Hercules, CA. (Hybrid 3 days)

6 month Assignment (Great potential to extend)

Pay Rate: $43/hr.

Schedule: M-F 8-5pm

On behalf of our client a medical device company, we are seeking for a Quality System Specialist II that will play a role in supporting the Northern California quality management Customer Request Process for Life Science and Clinical Diagnostics products. 

Job Responsibilities:

·       Facilitate the onboarding of the company as a supplier to key customers.

·       Supporting the intake, management, response, and closure of customer quality documentation requests.

·       Coordination and completion of supplier survey questionnaires for customers across a variety of business segments. 

·       Liaison with U.S. and International sales teams to prioritize high priority customer requests.

·       Coordination of product certificate of conformance, certificate of origin, declaration of conformity, and other applicable regulatory             and statutory documentation requests.

Education and Experience:

·       Associate degree or equivalent in Biology, Chemistry, or related field.

·       2+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.

·       Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).

·       Working knowledge of device/drug/biotech manufacturing processes.

·       Proficient in Microsoft Office, Visio and Excel

·       Salesforce and SAP experience is a plus