Supplier Quality Analyst: Medical Devices & Compliance

Stellar Consulting Solutions, LLC; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Stellar Consulting Solutions, LLC is seeking a Supplier Quality Analyst to ensure that suppliers meet quality and regulatory requirements for medical devices. The role involves managing supplier qualifications, monitoring performance using key metrics, and ensuring compliance with FDA regulations and ISO standards.

Ideal candidates should have a Bachelor's degree in Engineering or Quality, along with 2-5 years of relevant experience. Strong analytical skills, proficiency in Microsoft Excel, and excellent communication abilities are essential.

Qualifications

• 2-5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing.
• Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
• Strong understanding of regulated quality systems.

Responsibilities

• Manage and maintain supplier qualification, monitoring, and re-evaluation activities.
• Monitor supplier quality performance using KPIs.
• Ensure supplier quality documentation is accurate and complete.

Skills

Supplier Quality Management

Data Analysis

Regulatory Compliance

Microsoft Excel

Problem-Solving

Communication

Organizational Skills

Education

Bachelor’s degree in Engineering, Quality, or a related field

Tools

Windchill / PLM

Job description

Stellar Consulting Solutions, LLC is seeking a Supplier Quality Analyst to ensure that suppliers meet quality and regulatory requirements for medical devices. The role involves managing supplier qualifications, monitoring performance using key metrics, and ensuring compliance with FDA regulations and ISO standards.

Ideal candidates should have a Bachelor's degree in Engineering or Quality, along with 2-5 years of relevant experience. Strong analytical skills, proficiency in Microsoft Excel, and excellent communication abilities are essential.