Quality Assurance Manager - R2 Technologies, Inc.

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!