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:
Ability to Commute:
- Buena Park, CA 90624 (Preferred)
Work Location: In person
