DTx Quality Engineer (6 Month Contract)

Who We Are: Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. Responsibilities: Initiate and manage complaint records for investigational and commercial SaMD applications from receipt to closure in a timely and compliant manner. Maintain all records in a state of audit readiness ensuring compliance with internal procedures and applicable regulatory requirements. Evaluate incoming complaint information on whether reporting to applicable government agencies is required. Coordinate with cross-functional teams to gather investigation information and determine root cause of issues. Perform trend analysis on complaints and evaluate whether complaints result in a new or changed risk, initiating and coordinating updates to Risk Management File as applicable. Coordinate, in collaboration with cross-functional team members, quality aspects of release management including the scheduling and execution of software verification formal release. Support the creation of release documentation including testing plans and reports ensuring accurate configuration management and traceability. Maintain the log of known software anomalies initiating updates as anomalies are identified, including creating and maintaining nonconformance records as applicable, and ensuring timely cross-functional evaluation of the risk of each anomaly. Ensure the products’ Design & Development Files are maintained and updated in compliance with applicable regulations and standards. Assist product risk management activities to establish product risk assessments and trace the implementation of risk controls. Actively monitor for product risks and communicate/escalate as needed. Lead interdisciplinary design reviews at 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 management procedures. Qualifications: Embracing technological evolution is central to our DNA. Because AI defines our future, this role requires a proven ability to integrate AI technologies to drive innovation and impact. Bachelor’s Degree, preferably in engineering, or equivalent experience. 1- 5 years of experience in a medical device, software, or other technology field. Ability to oversee quality management activities within multiple simultaneous projects. Strong verbal and written communication skills to translate procedures into practice and effectively work with interdisciplinary teams and stakeholders. Attention to detail and ability to generate clear technical documentation/records (i.e., protocols, reports, test methods, justifications). Preferred: Experience working with software products through full lifecycle with knowledge of iterative agile planning, development and delivery. Preferred: Experience working with eQMS systems such as Enzyme or Ketryx. Required: Experience working with medical device quality management systems. Required: Familiarity with relevant SaMD standards and regulations such as FDA 21 CFR 820, ISO 13485, and IEC 62304. Compensation: $100-$120 per hour for 20 hours a week. 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. Recruitment Phishing Scams: Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at https://www.ic3.gov/Home/ComplaintChoice. Please be mindful of the following: Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams). Click Therapeutics will conduct interviews face-to-face over Zoom. All job postings will be listed on the Click Therapeutics official career page.