About the Position
Neocis Inc. is a venture-backed start-up company based in Miami, FL developing the next generation of robotic surgery systems. The Neocis team has a successful track record in pioneering robotic dental surgery. The company received FDA clearance for its Yomi robot-assisted dental surgery device in 2016. Neocis is growing fast and presents exciting career opportunities.
Neocis currently has the need for a Quality Analyst/Specialist. This is a great entry level opportunity for recent graduates and those with 3 years or less of medical device industry experience. You will be a core member of the quality and regulatory team that ensures Neocis develops high quality products compliant with FDA regulations. You will have the opportunity to work across several departments including Engineering, Manufacturing, and Marketing. You will be responsible for documenting, analyzing, and investigating customer complaints, and supporting the CAPA process. These very important primary responsibilities directly support Neocis compliance with FDA regulations. Additionally, you may participate in risk management and sustaining engineering. This role leaves room for merit promotion within Neocis.
- Bachelor of Science in Biomedical Engineering or equivalent from an ABET accredited program
- 0-3 years of experience in a Quality Assurance or Regulatory Affairs
- Aptitude for written communication
- Critical and analytical thinking
- General knowledge of engineering and human anatomy and physiology
- Microsoft Office Suite familiarity
- Personal responsibility and ability to work with minimal supervision
Role wish list:
- Experience in start-up environment
- Experience in FDA regulated industry
- Understanding of Quality System Regulations 21 CFR 820
- Ability to rapidly adapt to change
- Ability to take initiative
- Knowledge of robotics
- Public speaking skills
Please contact firstname.lastname@example.org. We’re looking forward to having you join our team.
(Direct inquiries only please; no recruiters).