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QA Engineer






Miami, FL, US


Neocis is a venture-backed start-up company based in South FL developing the next generation of robotic surgery systems. The team has a successful track record in robotic surgery, includes a team of world-class engineers and experts, and is backed by top-tier investors. The company has received FDA clearance following a successful clinical study and is in the process of commercialization. It is a ground-floor opportunity to get experience with a high-tech company that is poised to revolutionize surgery.

Neocis has several opportunities on the QA / RA team, so this posting is variable depending on the applicant’s level of experience and skill set. You will be a core part of the quality and regulatory team that ensures Neocis develops a high quality product within the guidelines of the FDA’s regulations for medical device development. You will have the opportunity to work across several departments including Engineering, Manufacturing, and Marketing. You will oversee the design of verification and validation protocols and reports and participate in risk analysis. Additionally, you will participate in several aspects of regulatory compliance including preparing submissions and meeting with the FDA.

We seek a candidate with the following skills and experience:
  • BS in Biomedical Engineering or equivalent
  • 2+ years of experience in a QA / RA role
  • Experience with quality assurance in a small start-up environment
  • Experience with FDA medical device regulations including 510(k) submissions
  • Thorough understanding of Quality Management Systems (QMS) and 21 CFR 820
  • Ability to understand and document complex technical information
  • Team player with excellent communication skills and strong attention to detail
Additional desirable skills and experience include:
  • Background and work experience as an engineer in developing a medical device
  • 10+ years of experience in a QA / RA role
  • Project/team lead experience
  • First-hand experience with medical device software, electronics and manufacturing
  • Experience with international standards like CE marks and ISO 9000

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