Quality Systems Specialist II

Quality System Specialist (2 Openings)
Plays a key role in supporting the Northern California quality management customer request process for Life Science (LSG) and Clinical Diagnostics (CDG) products.

Job Requirements:

• 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, or biotech manufacturing processes.
• Proficient in Microsoft Office, Visio, and Excel.
• Experience with Salesforce and SAP.

Job Responsibilities:

• Facilitate the onboarding of the company as a supplier to key customers.
• Manage the intake, response, and closure of customer quality documentation requests.
• Coordinate and complete supplier survey questionnaires for customers across different business segments.
• Prioritize high-priority customer requests in collaboration with U.S. and International sales teams.
• Coordinate regulatory and statutory documentation requests such as certificates of conformance, origin, and conformity.
• Create QMS survey response forms with cross-functional subject matter experts for frequently required customer requests.
• Facilitate review and approval of customer change and quality agreements.
• Review, verify, and close tasks related to product and process change management files.
• Draft customer notifications for marketing groups.
• Review manufacturing process deviations and non-conformances to determine if customer notifications are necessary per quality agreements.

Pay Details: $40.00 to $42.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance