The Senior Software Quality Manager manages the Software Quality group at the Boston-area Facility to develop and implement strategies and policies consistent with Company Goals in an ever-changing regulatory climate. The Senior Software Quality Manager ensures that Corporate Software initiatives are delivered in a compliant and timely manner and that strategies, SOP’s and development processes are understood and executed. This position ensures compliance in a fast evolving developmental, medical device, clinical laboratory and commercial environment. The Senior Software Quality Manager will prepare, evaluate and oversee software testing strategies.
Reporting to the Director of Software Quality and Data Privacy, this role will manage internal Software quality professional staff and/or consultants and direct and implement advancement of the Software Quality functions of iCarbonX.
Major Duties and Responsibilities:
- Develop quality strategies and act as the software quality liaison for development projects
- Support and monitor software quality control activities with adherence to the internal quality management system and pertinent Global QSR requirements for complex products and digital platforms
- Develop, maintain and continuously improve software quality standard operating procedures
- Work with supplier quality to approve software vendors and contractors.
- Support software change control activities, CAPA investigations, reviews, approvals, and/or CAPA plan implementations as needed.
- Train staff in quality policies or procedures.
- Travel up to 25%.
- Other duties as assigned
- BS/BA degree in computer science, engineering or related discipline.
- Minimum of 8 years of industrial experience in Software Quality or related discipline.
- Working knowledge of FDA Quality System Regulations (21 CFR Part 820 and Part 11) ISO 13485 (Quality Management for Medical Devices, Clinical Laboratory Improvement Amendments (CLIA) of 1988 and IEC62304.
Special Skills, Abilities, and Requirements:
- Exceptional written, oral, and interpersonal communication skills.
- Working knowledge of different software development life cycles (waterfall, iterative) and contemporary software quality assurance processes and automated tools.
- Experience in research and consumer products which are then further developed into diagnostic and medical devices preferred.
- Strong management and cross-group skills, including the ability to get what you need from others while working around their own legitimate priorities.
- Statistical knowledge a plus
- Ability to work in a complex, rapidly changing environment
- Excellent project management skills
- Strong leadership and mentoring skills
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive
- Demonstrated strong problem solving and risk management skills.
- Quality engineering certification (ASQ CQE or CQA) desired
This position is based in Cambridge, MA.
In April 2018, we formed the iCarbonX group with the merger of 3 companies - iCarbonX, 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 the art multi-omics technology platforms to digitalize biological data and apply insights gained from the process into development of medical and wellness products.
iCarbonX is an equal opportunity employer.