Nobio is a fast-growing materials technology company focusing on commercializing breakthrough antimicrobial technology. Infectious diseases are the third deadliest disease group and in three decades could be bigger than cancer, if resistant bacteria continue to emerge at the current pace. Most infections are caused by biofilm, which forms on almost anything. Nobio’s breakthrough, patented and clinically proven nanomaterial technology convert materials to antimicrobial, indefinitely, to prevent biofilm formation on their surface and causing infections. In dentistry, bacteria are the leading cause of treatments failure, and Nobio’s line of antimicrobial dental materials will launch in 2019, to disrupt a $3Bn market (first products recently FDA cleared). Nobio is also working with multiple leading manufacturers of dental, medical, consumer or industrial products for incorporating Nobio’s technology into their products and make them antimicrobial, indefinitely. For more, visit our website.
The individual for the job should be experienced in working within the medical device industry, preferable startups, with knowledge in FDA Quality System Regulation (QSR), ISO 13485:2016, and other applicable standards and regulations. He/she should have good communication skills and the ability to take strategic direction and establish efficient and compliant processes throughout the company.
Dynamic, fast-growing material science startup company with disruptive technology countering global challenges in multiple industries and areas of life, seeking an ambitious and energetic chemist/material scientist who’s ready to work hard to be an important contributor in a major change and company success.
Duties and Responsibilities:מדעים
מחקר ופיתוח | רפואה ופארמה
מנהל רגולציה ומע’ איכות
• Develop, administer and maintain QMS procedures and
activities required to ensure that the company’s processes and
products comply with applicable quality standards and
• Actively participate in all stages of design development, V&V
testing and design control activities, ensuring quality and
regulatory considerations and requirements are met.
• Lead the creation and maintenance of the DHF, DMR, and other
• Work with outside laboratories and institutes when third-party
testing is needed.
• Lead the Risk Management activities and failure investigations.
• Develop and implement quality control and inspection
procedures for receipt and control of incoming materials, in-
process materials and final product acceptance activities.
• Establish and maintain test instrument calibration procedures
and maintenance schedules
• Monitor and implement corrective and preventive actions.
• Identify quality assurance metrics; analyze and report trends to
• Lead the preparation for audits/inspections by regulatory
agencies and lead the audit on behalf of the company.
• Serve as the management representative.
• Other tasks as assigned by the CEO.
• Bachelor’s Degree, CQE training/certification a plus
• 5-10 years of experience working in a start-up, entrepreneurial
• Knowledge of FDA QSR, ISO 13485, ISO 14971 and familiar
with other medical device-related standards and regulations
• Excellent verbal and written communication skills
• Ability to work in a team-minded approach to achieve individual
and company success
• Fluent in computer skills and, at a minimum, the use of
Microsoft Office Word, Microsoft Office Excel, Microsoft Office
PowerPoint and Microsoft Office Project programs
• High attention to detail and thoroughness