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Compliance and Quality Assurance Coordinator
2 months ago
Job Summary:
TCWGlobal is seeking a highly skilled Quality Systems Specialist to support our Northern California quality management team. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities:
- Facilitate Supplier Onboarding: Collaborate with cross-functional teams to onboard new suppliers and ensure seamless integration into our quality management system.
- Customer Quality Documentation: Support the intake, management, response, and closure of customer quality documentation requests, ensuring timely and accurate resolution.
- Supplier Survey Coordination: Coordinate and complete supplier survey questionnaires for customers across various business segments, ensuring compliance with regulatory requirements.
- Liaison with Sales Teams: Liaise with U.S. and International sales teams to prioritize high-priority customer requests, ensuring timely resolution and customer satisfaction.
- Regulatory Documentation: Coordinate the creation and submission of product certificates of conformance, certificates of origin, declarations of conformity, and other applicable regulatory and statutory documentation requests.
- QMS Survey Response: Support the creation of key product QMS survey response forms, working with cross-functional subject matter experts to identify responses for frequently required customer requests.
- Customer Change and Quality Agreements: Facilitate the review and approval of customer change and/or quality agreements, ensuring compliance with regulatory requirements.
- Product and Process Change Management: Review, verify, and close tasks in support of product and process change management file activities, ensuring accurate and timely resolution.
- Customer Notifications: Support group marketing teams in drafting customer notifications, ensuring timely and accurate communication.
- Manufacturing Process Deviations: Review manufacturing process deviations and non-conformances for potential notification of customers per applicable quality agreements.
Requirements:
- Education: Associate degree or equivalent in Biology, Chemistry, or related field.
- Experience: 2+ years of experience in a regulated manufacturing industry within medical devices, drugs, or biotech.
- Regulatory Knowledge: Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
- Manufacturing Process Knowledge: Working knowledge of device/drug/biotech manufacturing processes.
- Soft Skills: Detail-oriented, excellent organization and project management skills, and ability to multitask.
- Technical Skills: Proficient in Microsoft Office, Visio, and Excel. Salesforce and SAP experience is a plus.
