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