Analyst, Quality Management Systems
Title Analyst, Quality Management Systems
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 Quality Management Systems Analyst has a key role in implementing and supporting Click’s Quality Management System to help align Click’s product life cycle processes and cross-functional operations with evolving medical device regulations and standards. Candidates must be proactive and creative in leading efforts to produce innovative process solutions to help accommodate Clicks pipeline progression, maintain compliance, and ensure Click’s standards of product safety, efficacy, and quality. The Analyst reports to the Director of Quality Management Systems.
Responsibilities
- Leading role in the implementation and oversight of Click’s Quality Management System processes throughout the organization
- Partners with cross-functional teams to find innovative and comprehensive operational solutions, and define and monitor performance metrics including quality objectives
- Manages Click’s electronic document management system, CAPA processing, complaint handling, and training processes
- Enhances quality system procedures and works closely with Engineering/Technology, Privacy and Security, Customer Care and other functional groups to effectively implement those procedures
- Conducts quality system audits and liaises in Notified Body, FDA, or other third-party audits
- Researches and monitors industry trends and publications, FDA news and announcements, and domestic and international regulations and standards to apply learnings so that Click remains on the leading edge of digital medicine
Qualifications
- 1-5 years of experience working in medical device, software, or other technology fields. Multiple experience levels encouraged to apply
- Bachelor’s degree in science, engineering, or a STEM-related concentration
- Highly motivated, driven, and excited about improving processes and procedures in an innovative, fast-paced environment
- Intellectually curious - Experience researching and interpreting regulations, policies, or similar for practical applications
- Strong attention to detail and ability to write clear procedures, status reports, or other technical writing
- Strong verbal and written communication skills to effectively implement system procedures, present on QMS activities to partners and other stakeholders, and provide QMS performance updates to management
- Strongly preferred: Experience in software development and/or working in the software industry, specifically agile development life cycles
- Preferred: Experience working with FDA 21 CFR 820 and ISO 13485 medical device quality management systems, European Medical Device Directive/Medical Device Regulation, and/or ISO 14971, IEC 62304, or other relevant standards
- Preferred: Experience working in environments governed by data privacy law such as HIPAA or GDPR
- Preferred: ASQ certification
Benefits
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.