Supplier Quality Engineer

About the role

The Supplier Quality Engineer ensures supplier performance meets the high standards required for medical device production. This role drives continuous improvement, manages supplier‑related risks, and supports regulatory compliance throughout the product lifecycle.

Key responsibilities

• Monitor supplier performance and analyze quality and delivery trends.
• Lead continuous improvement and supplier development initiatives.
• Investigate defects and non‑conformances, determine supplier responsibility, and conduct root cause analysis.
• Drive corrective and preventive actions through the SCAR process.
• Assess and manage Supplier Initiated Change Requests (SICRs) with proper validation and risk assessment.
• Plan and execute supplier audits in accordance with ISO 9001 and ISO 13485.
• Support internal and external audits and collaborate with Manufacturing, Engineering, Procurement, and Quality teams to ensure compliance and manufacturing continuity.

Required profile

• Minimum 2 years of experience in Quality, Manufacturing, or Supplier Quality Engineering, preferably in regulated industries such as medical devices.
• Bachelor’s degree in Engineering, Supply Chain Management, Electrical/Electronic Engineering, or a related field.
• Strong expertise in supplier quality management, data analysis, root cause analysis, CAPA methodologies, process validation, audits, and continuous improvement.
• Working knowledge of global medical device regulations and standards.
• Familiarity with statistical tools and quality methods.
• Proactive, risk‑based mindset with strong cross‑functional collaboration skills.

Required skills

• ISO 9001
• ISO 13485
• SCAR process
• Supplier Initiated Change Requests (SICR) management
• Root cause analysis
• CAPA methodologies
• Process validation
• Data analysis