Quality Engineer

Role Overview

Responsibilities

• Develop and maintain quality systems aligned with FDA Quality System Regulation requirements and applicable ISO standards.
• Support design control throughout the product lifecycle, including risk management, verification, validation, and design transfer.
• Perform root cause analysis using FMEA, 5-Why, and Fishbone diagrams.
• Lead CAPA activities and resolve nonconformances through documented investigations.
• Collaborate with design, manufacturing, regulatory, and quality teams.
• Analyze quality data using statistical techniques and monitor process performance.
• Support IQ, OQ, and PQ validation activities for processes and equipment.
• Maintain compliant quality records and contribute to continuous improvement.

Essential Skills and Qualifications

• Strong knowledge of ISO standards for quality management and risk management.
• Strong knowledge of FDA Quality System Regulation requirements.
• Experience with CAPA processes, nonconformance handling, and root cause analysis.
• Experience in medical device quality engineering or a similarly regulated environment.
• Ability to support design control, risk management, verification, validation, and design transfer.
• Strong analytical, problem-solving, documentation, and communication skills.

Work Environment

• The role operates in a regulated medical device environment focused on ISO standards and FDA requirements.
• The position involves documentation, analysis, design control, validation activities, and process improvement with cross-functional teams.

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