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Spec 3, Quality Assurance
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Spec 3, Quality Assurance
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Spec 3, Quality Assurance
- Irvine, California, United States
- Irvine, California, United States
Über
Job Summary
The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820), ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
Key Responsibilities
Manage and maintain supplier qualification, monitoring, and re‑evaluation activities in accordance with 21 CFR 820.50 (Purchasing Controls) and ISO 13485.
Monitor supplier quality performance using KPIs such as defect rates, corrective action trends, and supplier risk levels.
Maintain approved supplier lists (ASL) and supplier quality records per document control requirements.
Issue, track, and evaluate Supplier change requests.
Escalate supplier quality risks and support remediation and improvement plans.
Review and support supplier‑initiated or internally driven changes that may impact product quality or compliance (materials, processes, manufacturing location).
Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation, verification, or regulatory impact evaluation.
Provide supplier quality input for management reviews and quality metrics.
Ensure supplier quality documentation is accurate, complete, and maintained in the electronic Quality Management System (eQMS).
Ensure supplier activities comply with internal procedures, regulatory requirements, and quality system expectations.
Required Qualifications
Bachelor's degree in Engineering, Quality, or a related field; or equivalent experience.
25 years of experience in Supplier Quality, Quality Assurance, or Manufacturing within a medical device or other regulated environment.
Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
Proficiency in Microsoft Excel and data analysis.
Key Skills & Competencies
Strong understanding of regulated quality systems
Analytical, detail‑oriented problem‑solving mindset
Clear written and verbal communication
Ability to influence suppliers and internal stakeholders
Strong organizational and time‑management skills
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Sprachkenntnisse
- English
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