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Posted on April 21, 2022 in US Jobs

QA/RA Manager

Who We Are

binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing for male and female samples. We also have a broad suite of offerings in sample collection for large corporate partners for broadened access to STI and COVID-19 care. Our molecular point of care platform brings rapid, accurate, and convenient infectious disease testing to people where they live, work, and shop. Our solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven sample collection and laboratory testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.

The Position

The Quality Assurance Manager will develop and implement effective processes for the development and commercialization of binx products. Working closely with binx leadership and operational colleagues, this position is responsible for establishing processes to ensure laboratory products are designed and developed in accordance with relevant standards and in a controlled manner.

With input from appropriate stakeholders, this individual will create a new standardized process for developing and launching products in the binx everywhere digital program that facilitates relationships between patients and clinicians, such as binx’s current offerings for STI and COVID-19 testing. The Quality Assurance Manager will also systematically assist operational departments to establish lean and effective processes assuring binx provides high-quality products and services to our customers.

Initially, this role will be that of an individual contributor with room to grow in scope and responsibility as the organization grows.

Responsibilities

  • Establish and implement processes for launching laboratory products in accordance with standards, guidelines, and industry best practices
  • Build a documentation portfolio that supports the controlled launch of laboratory products
  • Partner with operational departments to establish lean and effective processes
  • Educate colleagues in all departments about Quality Assurance principles and the standards that apply to the manufacture of in vitro diagnostics and laboratory medicine
  • Support the Sr. Director, Quality Assurance in the application of the Quality Management System
  • Assist in the general duties of the Quality Assurance team such as document control, internal audits, customer feedback, nonconformance and CAPA management, supplier evaluation, training, etc.
  • Support the Director, Regulatory Affairs in planning and executing binx’s transition to IVDR and UKCA compliance and in the preparation of regulatory submissions
  • Other duties as assigned

Education, Experience, and Demonstrated Skills

  • Requires a BA/BS degree
  • Required 8 – 10 years related Quality Assurance or Regulatory Affairs experience within the laboratory medicine and medical device industries
  • Good working knowledge of applicable regulations and harmonized standards (21CFR820, ISO13485:2016, CLIA, HIPAA)
  • High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction.
  • Excellent interpersonal and strong leadership skills; self-motivated and flexible to changing schedules.
  • Willingness to periodically travel to our UK offices

binx health, Inc. is an Equal Opportunity Employer For interested applicants, please submit resumes to careers@mybinxhealth.com