Analyst, Quality Management Systems at Click Therapeutics

| Greater NYC Area
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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.

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Technology we use

  • Engineering
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • RubyLanguages
    • Open and diverse tech stackLanguages
    • jQueryLibraries
    • ReactLibraries
    • ReduxLibraries
    • AngularJSFrameworks
    • Ember.jsFrameworks
    • Node.jsFrameworks
    • Ruby on RailsFrameworks

Location

Our trendy TriBeCa HQ is in the heart of downtown Manhattan, easily accessible by subway, and includes free, unlimited office snacks and beverages.

What are Click Therapeutics Perks + Benefits

Culture
Friends outside of work
Daily stand up
Open door policy
Open office floor plan
Diversity
Unconscious bias training
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Game Room
Stocked Kitchen
Some Meals Provided
Happy Hours
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
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