Senior Quality Engineer

Senior Quality Engineer to lead and maintain the Quality Management System (QMS) for orthodontic software and aligner products. This role will ensure compliance with global standards like ISO 13485, FDA 21 CFR 820, MDSAP, and more, while collaborating with cross-functional teams to drive quality improvements and regulatory readiness.

Key Responsibilities:

• Develop and manage QMS to meet regulatory standards (FDA, ISO 13485, CMDR, EU MDR, etc.)
• Lead audits, CAPAs, complaints handling, risk management, and design controls
• Analyze quality data and trends to improve products and processes
• Support post-market activities, including customer feedback and software updates
• Administer and maintain eQMS systems and ensure inspection readiness

Qualifications:

• 5-7+ years of Quality Engineering experience in medical devices
• Expertise in regulatory standards (FDA, ISO 13485, CMDR, etc.)
• Strong communication and problem-solving skills
• Bachelors degree in engineering or a related field