Quality System Specialist II

Job Description

Job Description

Quality System Specialist II

The Quality System Specialist will play a role in supporting the Northern California quality management Customer Request request Process for Life Science (LSG) and Clinical Diagnostics (CDG) products.

Daily activities would include :

• Facilitate the onboarding of 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.

Requirements :

Support creation of key product QMS survey response forms working with cross-functional subject matter experts to identify responses for the most frequently required customer requests.

• Facilitate the review and approval of customer change and / or quality agreements.
• Review, verify, and close tasks in support of product and process change management file activities.
• Support group Marketing groups in drafting customer notifications.
• Review manufacturing process deviations and non-conformances for potential notification of customers per applicable quality agreements.
• 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.
• Detail-oriented, excellent organization and project management skills and ability to multitask.
• Decision making, time management, organization, communication, leadership, and computer skills.
• Proficient in Microsoft Office, Visio and Excel
• Salesforce and SAP experience is a plus
2 days ago