Quality Engineer (Medical Devices)

About the role

We are seeking a Quality Engineer to ensure the quality and regulatory compliance of medical device products throughout their lifecycle. You will work closely with cross‑functional teams to implement quality systems and drive continuous improvement.

Key responsibilities

• Lead risk management, process validation, and design verification activities in line with FDA, ISO 13485, and MDR standards.
• Investigate and resolve complex quality issues using root‑cause analysis (RCA) and implement corrective and preventive actions (CAPA).
• Provide quality engineering support to manufacturing, design, clinical, and regulatory teams.
• Develop, review, and maintain process and product documentation, including procedures, work instructions, and control plans.
• Analyze quality data, monitor trends, and lead continuous‑improvement projects.
• Ensure compliance through audits, inspections, and documentation reviews.
• Mentor junior quality engineers and facilitate training on quality system requirements.

Required profile

• Bachelor’s degree in Engineering or related field (Master’s preferred).
• 3+ years of quality engineering experience in the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, MDR, and cycle validation.
• Proficiency in risk management, process validation, statistical analysis, and root‑cause analysis methodologies.
• Demonstrated ability to lead cross‑functional teams and projects.
• Excellent communication, documentation, and problem‑solving skills.
• ASQ certification (CQE, CQA, CMQ/OE) or Six Sigma Green/Black Belt preferred.

Required skills

• Risk management
• Process validation
• Statistical analysis
• Root cause analysis
• FDA regulations
• ISO 13485
• MDR
• Cycle validation
• ASQ certification (CQE, CQA, CMQ/OE)
• Six Sigma Green Belt
• Six Sigma Black Belt