SaMD Quality Intern

Click Therapeutics, Inc.

Feb 15, 2024

Applications are closed

Internship
Part-time
Starts on May 14
Off-cycle Internship
Science
New York

Requirements

Rising Junior or Senior Undergrad.
Current student of a 4-year program with a strong academic record.
Excellent verbal and written communication skills.
Detail oriented, with consistent organizational skills.
Enthusiastic about digital health and healthcare innovation.
Preferred Qualifications:
Pursuing a degree in Biomedical Engineering, Biological Engineering, or similar.
Experience writing SOPs or other technical writing (in a science or engineering field).
Familiarity / working knowledge of software programming language(s).
Working knowledge of medical device standards and regulations such as FDA 21 CFR.
Part 820, ISO 13485, ISO 14971, and IEC 62304.

Responsibilities

Participate in the implementation and oversight of Click’s Quality Management System (QMS) processes throughout the organization.
Support product development processes, such as risk management and design review, to ensure product development compliance with regulatory and quality standards throughout the Software Development Lifecycle.
Work within Click’s electronic QMS document management system with CAPA records, complaints, training records, etc.
Review design documentation including product requirements, design specifications, verification/validation test plans and reports. Maintain records as part of the products’ Design History File (DHF).
Enhance quality system procedures to enable on-going process improvements and the expansion of Click’s quality system to support product commercialization in world-wide markets.
Research and monitor SaMD and DTx industry trends and publications, FDA news and announcements, and international standards. Apply learnings to the Quality Management System.

Click Therapeutics, Inc.

Science & Healthcare

Industry

51-200

Employees

2012

Founded Year

Mission & Purpose

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™, we deliver accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Our treatments are defined by our 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. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. Digital therapeutics under development on our platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, cardiology and immunology. Consistently named a best place to work, we foster an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in our mission to provide patients everywhere access to safe and effective prescription digital therapeutics.