Convergent Dental

QA Engineer

• Serve as the quality representative on design and development projects, from concept through commercialization.
• Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Lead and support design control activities: risk management (ISO 14971), design inputs/outputs, verification and validation, design reviews, and design history file (DHF) maintenance.
• Develop and implement quality plans, test strategies, and protocols for new product development.
• Drive root cause analysis and corrective/preventive actions (CAPA) related to product design and development.
• Monitor and analyze quality metrics and trends.
• Support development and continuous improvement of the Quality Management System.
• Review and approve Engineering Change Orders (ECOs), test protocols, and technical documentation.
• Collaborate with Product Management, Engineering, R&D, Regulatory, Manufacturing, Customer Success and Clinical teams to ensure quality is integrated throughout the product lifecycle.
• Support internal, external audits and regulatory inspections.
• Participate in post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls.
• Analyze post-market data and trends to identify opportunities for product and process improvements.

Quality Engineer