The Quality Assurance Manager is responsible for executing the company’s Quality strategy and policies. This position reports to the Director of Quality and ensures quality compliance for validation, CAPA, and continuous improvement activities.
HealthTell is now a central part of iCarbonX’s Digital Life Alliance along with Cambridge, MA based PatientsLikeMe; this represents an unprecedented ecosystem of leading bio, health networking, sequencing and artificial intelligence technology companies.
This position is based in Chandler, Arizona but may support other company and Alliance partner locations as needed.
Quality Lead for manufacturing validation efforts, CAPA and continuous improvement activities.
Provides GMP regulatory compliance guidance (FDA, EU & HC) for GMP operations.
Collaborates with Manufacturing, and other departments to implement quality strategies.
Manages Quality activities as they relate to investigations, risk management, etc.
Other duties as required
Bachelor’s degree in bioengineering or related field; advanced degree preferred
5+ years of experience in a biotech company leading quality systems.
Proven GMP knowledge
Working knowledge of ISO 13485:2016 and FDA 21 CFR: Quality System Regulation
Proven ability to work effectively with Manufacturing and other functional groups.
Strong scientific, problem solving and analytical acumen in engineering or biochemistry.
Proven Risk Management skills
Statistical knowledge a plus
Certified Lead auditor accreditation a plus
Strong project management skills with an emphasis on critical thinking and problem solving
Proven written and verbal communication skills
Can travel domestically, up to 5%
In April 2018, we formed the iCarbonX group with the merger of 3 companies - CarbonX, PatientsLikeMe, and HealthTell. Our vision is to fundamentally transform the healthcare & wellness of individuals & communities by unlocking the power of deep & dynamic digitization of biological information. By combining multi-omics biological data, smart device biophysical data and patient’s phenotypic data with artificial intelligence, iCarbonX will enable a real-time, deep assessment on one’s health and wellness, and deliver a personalized guide and range of products to help people live a healthy, longer life. To achieve our vision, we are developing state of art multi-omics technology platforms to digitalize biological data and apply insights gained from the process into development of medical and wellness products.