What are the responsibilities and job description for the Supplier Quality Engineer position at Indotronix Avani Group?
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.
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.
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