Dtx Quality Engineer Job at Click Therapeutics (New York)

Job Description

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.

Job Responsibility

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

Requirements

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
Proven ability to integrate AI technologies to drive innovation and impact

Nice to have

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

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Dtx Quality Engineer

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