Neocis is an established start-up revolutionizing dentistry with Yomi, the first, and only FDA cleared robot for assisted dental surgery. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Florida. Neocis is venture-backed with funding from several prominent investors.

The Role : The Quality Engineer (QE) will be a core part of the quality team that ensures Neocis develops a high-quality product within the guidelines of the FDA’s regulations for medical device development. The main responsibility of this position is to support product/process changes based on complaint handling and CAPA. In addition, the Quality Engineer will also provide QE support to new design projects which are under during design control. As this is a start-up company, the QE will also have the opportunity to work across several other departments when needed including Regulatory, QA/QC, Quality Ops, and QMS. The QE will be part of the complaint handling and CAPA review team to support the implementation of product improvements as needed. The QE will also be involved in all aspects of the development of product improvements driven by product complaints/CAPAs and new design projects (e.g., root cause investigation, action planning, design input/output definition, design verification and validation, and design transfer).

• Complete risk assessment and lead investigations for incoming complaints
• Review incoming complaints for MDR determination
• Escalate issues to CAPA or HHE as needed
• Manage CAPA investigation, implementation and effectiveness verification
• As part of an engineering project, devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment during design transfer.
• Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
• Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools
• Analyze complaint data to identify trends, issues or systemic discrepancies
• Participate in internal and external audits
• Analyze and provide complaint data reports for QRB and Management Review Meetings
• Develop and maintain product knowledge of existing and new products
• Work closely with the Quality leadership team to establish Quality Performance Metrics