Neocis · 17 hours ago
Quality Engineer
Miami, FL
Full-time
Onsite
Entry Level
1+ years expNeocis is an established start-up revolutionizing dentistry with Yomi, the first, and only FDA cleared robot for assisted dental surgery. The Quality Engineer is responsible for providing Quality Engineering support to ensure compliance with FDA and ISO 13485, including supporting the manufacturing quality function during production and shipment of products.
DentalHealth CareMedical DeviceRobotics
Responsibilities
Perform complaint, nonconformance and CAPA reviews, investigations, containment plans and resolutions
Process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy and FDA regulations
Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report
Follow all applicable Quality and Safety procedures, including Good Documentation Practices (GDP)
Recommend revisions of specifications, and help formulate or revise quality assurance policies and procedures to ensure alignment with regulatory requirements and best practices
Create monthly Quality Dashboards for leadership, highlighting trends in nonconformances or production yields
Design or specify inspection and testing mechanisms and equipment to monitor and assess product quality throughout the manufacturing process
Support Manufacturing and Quality Control departments to ensure successful manufacturing and release of products by following company standard operating procedures and process control requirements
Support research and development and manufacturing departments to ensure successful transition of products and processes from design to commercialization by following company standard operating procedures and design control requirements
Develop and Implement statistical methods to support process and product improvement activities
Maintain effective communications with supervisor and peers in daily activities
Participate in inspection support for FDA and global regulatory agencies, including research and preparation of correspondence in response to global regulatory agencies requests for additional information
Qualification
Required
Bachelor's Degree (B.S.) in Biomedical Engineering or equivalent from four-year college or university is needed
1 year of experience in a Quality Assurance role in a regulated industry
Thorough understanding of Quality Management Systems (QMS), 21 CFR 820, CE Mark, ISO 13485 standards is needed
Ability to understand and document complex technical information
Team player with excellent communication skills and strong attention to detail
Computer knowledge is required
Ability to read, analyze, and interpret common scientific and technical journals and standards
Ability to effectively present information to various internal and external customers
Preferred
Experience with quality assurance in a small start-up environment is desired
Background and work experience as an engineer in developing a medical device is an advantage
Project/team lead experience is a plus
Benefits
Sabbatical
Parental leave
Unlimited PTO policies
Generous 401K plan with 4% company match
Comprehensive benefits package that includes medical, dental and vision
Company
Neocis
Neocis develops robot-assisted dental implant surgery with the aim of transforming dental surgery using advanced robotics.
51-200 employees
H1B Sponsorship
Neocis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (12)
2022 (5)
2021 (4)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$183.1MKey Investors
DFJ GrowthNational Science FoundationPropel(X)
2024-01-10Series D· $20M
2022-10-27Series D· $40M
2020-10-08Series D· $72M
Leadership Team
Alon Mozes
CEO and Co-founder
Juan Salcedo
Engineering Fellow Co-Founder
Recent News
2026-01-07
Company data provided by crunchbase