Product Quality Engineer

Overview

Product Quality Engineer supporting design controls, quality management, risk management, and sustaining initiatives for medical devices.

What you'll do

• Lead quality elements of design controls and product Design History Files.
• Drive quality activities for design engineering projects.
• Integrate risk management across the product lifecycle.
• Analyze field performance to identify post-market trends and risks.
• Support regulatory submissions and respond to submission questions.
• Lead CAPA and quality management system improvement initiatives.
• Transfer quality deliverables to manufacturing, operations quality, and supplier quality teams.

What you'll need

• 8–10 years of experience in quality engineering, safety engineering, R&D engineering, or an equivalent area.
• Bachelor's or master's degree in mechanical engineering, electronics engineering, science, or an equivalent field.
• Experience with ISO 14971, 21 CFR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304.
• Knowledge of data analysis and interpretation.
• Knowledge of root cause analysis and CAPA methodologies.
• Experience with regulatory requirements, risk assessment, and technical documentation.
• Knowledge of product lifecycle management and defect management.

Nice to have

• Six Sigma Green Belt certification.

Details

• Location: Bangalore.