About Us:

　　Headquartered in Silicon Valley, R2 Technologies is the world leader in CryoAesthetics™ medical devices. Our Glacial® platform for precision contact cooling of the skin has been shown to reduce inflammation and also brighten dark spots.

　　In 2014, Pansend Life Sciences, LLC, the life sciences segment of INNOVATE (NYSE: VATE), founded R2 together with Blossom Innovations, LLC and Massachusetts General Hospital to develop a technology based on their patented method of CryomodulationTM. In 2019, R2 brought on a strategic partner, Huadong Medicine Co., Ltd.

　　Since that time, R2 has conducted the design, development and extensive clinical research to bring Glacial® Rx, Glacial® fx and Glacial® Spa to market along with an exciting product pipeline. 

　　About You:

　　You will be responsible for providing quality assurance management for quality system requirements associated with medical devices. Specific areas of support may include, product complaints, quality data tracking, trending, and analysis, quality events/product shortage execution, supplier controls, product quality review, risk management, agency inspections/internal audits, CAPA, NCMRs, and overall quality manual requirements. This position will ensure that all product, process, and system related quality activities supporting the business are in compliance with corporate, governmental, and local regulations and requirements. You would report to the Director of RA & QA. We are an EOE. 

　　Essential Responsibilities include the following (other duties may be assigned):

　　Lead, develop, and manage effective and compliant quality systems and working closely with various cross functional members to ensure all requirements are described and meet the needs of regulations and functional excellence

　　Assist with the integration and support of quality system regulations

　　Evaluate, analyze, and trend quality indicators, data, and performance metrics; communication and elevation of compliance status and risk while maintaining a continuous improvement objective

　　Partner, coordinate, and support activities related to production, including product inspections and facility inspections

　　Quality management of supplier qualification program including performance monitoring for key supplier

　　Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans

　　Assist project teams in planning, preparation, review, and approval of quality documentation

　　Coordinate the Quality Management Review process

　　Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions

　　Ensure metrics and KPIs are being met

　　Represent QA in regional, global, and cross functional teams, projects, and programs, as assigned by management

　　Qualifications and Education Requirements:

　　Bachelor’s Degree in Engineering or Life/Health Sciences

　　Six (6) years of experience in Quality Assurance

　　Proficient in all MS Office applications

　　Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21 CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, EU MDR, ISO 14971, and ISO 13485 etc.

　　Prior experience in medical device manufacturing environment

　　Ability to identify the strategic direction of the quality assurance system

　　Ability to analyze and interpret all regulatory and quality guidelines as needed

　　Certification(s) – ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality Auditor preferred

　　Physical Requirements:

　　Ability to travel 10% locally

　　Ability to sit, stand and/or walk for no less than 8 hours a day

　　Ability to lift a minimum of 25 pounds

　　Ability to view computer screen for long-durations

　　Benefits:

　　Fully distributed work force - this position requires trips to our office location in Dublin, CA as needed

　　Company paid medical, dental, and vision insurance

　　401K plan, with company match

　　Generous stock options

　　Plus, much more!

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