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 PatientsLikeMe and HealthTell as members of the iCarbonX Digital Life Alliance.
Major Duties and Responsibilities:
- Develop quality strategies and act as the software quality liaison for development projectsSupport 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
About iCarbonX Digital Life Alliance
PatientsLikeMe and HealthTell are now a central part of iCarbonX’s Digital Life Alliance; this represents an unprecedented ecosystem of leading bio, health networking, sequencing and artificial intelligence technology companies. The alliance is working to combine biological and patient generated data with artificial intelligence technology to more rapidly detect meaningful signals about health, disease and aging, deliver a personalized guide for living a healthy life, and help industry learn even more about how to improve outcomes, and lives.
PatientsLikeMe, the world’s largest personalized health network, helps people find new options for treatments, connect with others, and take action to improve their outcomes. The company has worked with every major pharmaceutical company and a range of government organizations to bring the patient voice to research, development and public policy. With 600,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 100 research studies.
HealthTell is a well-funded Life Sciences company that is commercializing the ImmunoSignature™ technology for accurate and timely detection, and monitoring progression of chronic diseases. Based on a robust, scalable, proprietary technology, the company will provide the first and only diagnostic platform capable of detecting the presence of disease, stratifying patients, and monitoring disease progression. The ImmunoSignature™ technology is unlike any other, measuring the immune system instead of relying on inaccurate biomarkers or radiographic images. The ImmunoSignature™ Test will enable physicians to detect disease at an early stage, resulting in improved outcomes and reduced healthcare expenditures.
HealthTell is an equal opportunity employer.