Quality Engineer

Neocis•Miami, FL

5d•Onsite

About The Position

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. What’s in it for you? You’ll thrive in our innovative and collaborative environment Make an immediate impact on life-changing technology Avoid silos and “not my job” mentality in our smaller, fast paced, startup environment We offer sabbatical, parental leave and unlimited PTO policies Generous 401K plan with 4% company match Comprehensive benefits package that includes medical, dental and vision The Role: The Quality Engineer is responsible for providing Quality Engineering support to ensure compliance with FDA and ISO 13485. This also includes supporting the manufacturing quality function of the company during ongoing production and shipment of Neocis products to the field.

Requirements

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

Nice To Haves

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.

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.