Supplier Quality Engineer

Indotronix Avani Group; Irvine (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Indotronix Avani Group in Irvine, California is seeking a Supplier Quality Analyst to ensure compliance with quality and regulatory standards for suppliers of medical device components. The role involves managing supplier qualification, monitoring performance, and collaborating with engineering and regulatory teams.

The ideal candidate will have 2-5 years of relevant experience and a Bachelor's degree in Engineering or Quality. Proficiency in Microsoft Excel and knowledge of industry regulations are essential for success in this position.

Qualifications

• 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 regulated environment.
• Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
• Proficiency in Microsoft Excel and data analysis.

Responsibilities

• Manage and maintain supplier qualification, monitoring, and re-evaluation activities.
• Monitor supplier quality performance using KPIs such as defect rates and corrective action trends.
• Collaborate with Engineering and Regulatory Affairs for supplier change assessments.

Skills

Supplier Quality Management

Quality Assurance

Data Analysis

Regulatory Compliance (FDA, ISO)

Education

Bachelor's degree in Engineering or Quality field

Tools

Microsoft Excel

Job description

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.

Required Qualifications

• 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.