DTx Quality Engineer (6 Month Contract)

Click Therapeutics•New York, NY

12h

About The Position

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.

Requirements

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).
Experience working with medical device quality management systems.
Familiarity with relevant SaMD standards and regulations such as FDA 21 CFR 820, ISO 13485, and IEC 62304.

Nice To Haves

Experience working with software products through full lifecycle with knowledge of iterative agile planning, development and delivery.
Experience working with eQMS systems such as Enzyme or Ketryx.

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.