Title DTx Quality Analyst, Quality Management
Location TriBeCa, New York City, United States
Who We Are
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Major pipeline expansion and progression is in process.
About the Role
The DTx Quality Analyst has a key role in the development of Click’s Software as a Medical Device (SaMD) mobile applications. This position is part of the Quality Management team and works alongside Product Management, Technology and Engineering, the Software Testing team, and others to help align Click’s Agile software development processes and other operations with evolving FDA and global medical device regulations and standards. This individual must be proactive and creative in devising innovative solutions to complex production issues, and take part
in interdisciplinary efforts to help ensure that Click’s medical device software meets the highest standards of safety
and efficacy when brought to market.
- Leading role in implementation and oversight of Click’s Quality Management System processes throughout the organization with a focus on product development and performance
- Work cross-functionally to ensure that Click’s software product development life cycle activities are compliant with design control and related processes
- Work closely with interdisciplinary teams and with Click’s commercial partners to effectively produce and execute design and development plans
- Drive product risk management activities to establish product risk assessments, actively monitor and manage product risks, and trace the implementation of risk control
- Lead interdisciplinary design reviews at major product development milestones.
- Enable clear communication, prioritization, and decision making across teams to efficiently document and help manage the handling of product changes and incidents per Click’s quality system procedures
- Coordinate quality aspects of release management including the scheduling and execution of software verification, clinical validation, and formal release with product management and testing teams.
- Maintain the product’s Design History File (DHF) for 510(k) and other regulatory submissions
- Identify and innovate in areas where manual work can be automated and drive on-going process improvements, and collaborate with the other Quality Management teams to continually enhance operational procedures
- 1-4 years of experience working in a medical device, software, or other technology field
- Bachelor’s Degree in Engineering preferred
- Ability to oversee quality management activities within multiple simultaneous projects
- Experience working with software products through the full Agile development lifecycle with knowledge of development planning, design and implementation, and delivery
- Strong verbal and written communication skills to effectively communicate procedures and work collaboratively with interdisciplinary teams and stakeholders
- Strong attention to detail and ability to generate clear technical documentation/records (i.e., protocols, reports, test methods, justifications)
- Preferred: Experience in Software as a Medical Device (SaMD) or general medical device software development
- Preferred: Experience working with medical device or other Quality Management Systems
- Preferred: Familiarity with medical device regulations and standards such as FDA 21 CFR 820, ISO 13485, IEC 62304, AAMI TIR45, ISO 14971, and ISO 62366
Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…
Equal Employment Opportunity
Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.