Supplier Quality Engineer
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-06-18
Listing for:
Indotronix Avani Group
Full Time
position Listed on 2026-06-18
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation, verification, or regulatory impact evaluation.
- Bachelor’s degree in Engineering, Quality, or a related field; or equivalent experience.
- 2-5 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.
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