Job Summary The Supplier Quality Manager leads the Supplier Quality Management program for raw materials, components, packaging, and contract manufacturing/testing partners supporting OTC drug and medical device production. This role owns supplier qualification, ongoing performance monitoring, quality agreements, and supplier-related nonconformance and CAPA activity to ensure incoming materials consistently meet specifications and regulatory requirements. Duties Develop, implement, and maintain the Supplier Quality Management program, including risk-based supplier qualification, approval, and requalification/periodic review processes. Establish and negotiate Quality Agreements with suppliers and contract manufacturers/testing labs, defining roles, responsibilities, change notification requirements, and quality expectations. Plan and execute supplier audits (on-site and remote) to assess compliance with 21 CFR 210/211, 21 CFR 820, ISO 13485, and applicable component/material standards; manage audit scheduling, reporting, and follow-up on corrective actions. Own the Approved Supplier List (ASL) and Approved Vendor List (AVL), ensuring risk classifications, approval status, and requalification dates are current. Lead investigation and disposition of supplier-related nonconformances, incoming material rejections, and complaints; drive supplier CAPAs to closure and verify effectiveness. Partner with Purchasing/Supply Chain, Operations, and R&D to evaluate and qualify new suppliers, alternate sources, and raw material/component changes, including first-article inspections and qualification protocols. Review and approve supplier-submitted Certificates of Analysis (COA), Certificates of Compliance (COC), and validation/qualification documentation for incoming materials and components. Monitor and report supplier performance metrics (on-time delivery quality, reject rates, CAPA closure rates, audit findings) via supplier scorecards; lead periodic supplier business/quality review meetings. Manage supplier change notifications, assessing potential impact to product quality, regulatory filings, and validated processes; coordinate internal change control as needed. Support regulatory inspections and customer audits by presenting the Supplier Quality program and supporting documentation. Mentor and may functionally direct QA staff supporting incoming inspection and supplier-related quality activities. Requirements Bachelor's degree in a scientific, engineering, or quality-related discipline; advanced degree or ASQ certification (CQA, CSQP, CQE) a plus. 5-8+ years of supplier quality, quality assurance, or quality engineering experience in OTC pharmaceutical, medical device, or other FDA/ISO-regulated manufacturing, including direct supplier audit experience. Strong working knowledge of 21 CFR 210/211, 21 CFR 820, ISO 13485, ISO 9001, and applicable component/packaging standards. Demonstrated experience leading supplier audits, qualification protocols, and supplier CAPA/nonconformance investigations. Excellent negotiation, communication, and cross-functional leadership skills; ability to influence supplier and internal stakeholder behavior without direct authority. Willingness and ability to travel to supplier/contract manufacturing sites as needed. Lead Auditor certification (e.g., ISO 13485 or

ISO 9001

) preferred. Join us to be at the forefront of ensuring top-tier product quality through innovative supplier management! We are committed to fostering a collaborative environment where your expertise will directly influence our success in delivering reliable products that meet rigorous industry standards.

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Education:

Bachelor's (Preferred) Ability to

Commute:

Buena Park, CA 90624 (Preferred)

Work Location:

In person