Quality Assurance Manager (SaMD)

Company Overview
Idea Evolver specializes in leveraging data to inform innovative digital product development strategies, content marketing, and search experience optimization for Fortune 1000 companies with offices in New York and Philadelphia.
Notable clients include AstraZeneca, Dannon, Sandoz, Merck, United Therapeutics, and Teva.

Responsibilities and Duties
  • Ensure internal documentation and processes meet applicable regulatory compliance needs for a Software as a Medical Device (SaMD) product
  • Act as a regulatory and compliance resource for both internal teams and external clients
  • Review external validation and verification deliverables ensuring they meet regulatory compliance needs
  • Perform internal audits of Idea Evolver’s QMS system
  • Perform regular QMS and regulatory trainings for Idea Evolver’s engineering, product, media and quality assurance teams
  • Write and prepare quality QMS documentation and reports for regulatory audits
  • Develop and monitor key KPIs for QMS system’s quality and effectiveness
Qualifications and Skills
  • Bachelor’s degree in Engineering, Physical Science or Life Science disciplines
  • Minimum two to three years of experience in a Quality Assurance or equivalent role
  • Knowledge of Medical Device regulatory frameworks (21 CFR 820, 21 CFR 11, ISO 13485:2016, ISO 14971, IEC 62304:2006, SaMD, FDA GxP, FDA QSR and HIPAA)
  • Knowledge and understanding of the Medical Device Software Development Life Cycle (v-model)
  • Understanding of regulatory processes such as adverse event reporting, change request documentation, risk assessment analysis, CAPA, defect management, and design controls documentation
  • Ability to work independently on a small dynamic team in a fast-paced environment
Nice to Haves
  • ASQ Quality Certification or Regulatory Affairs Certification (RAC)
Benefits and Perks
  • Competitive Salary
  • Excellent health and dental
  • 401k
  • Flexible work from home schedule
  • Working on projects that bring measurable beneficial impacts to patients facing a diverse range of healthcare related needs
 

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