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Director – Software Quality
Posted on 11/26/2022
San Bruno, CA, USA • Remote
Experience Level
Desired Skills
  • BS degree in Life Sciences or Engineering
  • Energetic expert in IEC 62304 and GAMP5
  • Well-versed in ISO 13485:2016 and 21CFR820
  • Proven track record of building and implementing Quality processes for software teams
  • Proven track record of participating/leading software development initiatives from concept to market
  • Positive and dynamic servant-leader who can both strategically lead teams and roll up sleeves to complete tasks
  • 7+ years in a regulated life sciences company
  • 2+ years of experience managing direct reports
  • 2+ years of formal or informal experience in project management
  • Experience with in vitro diagnostic devices (IVD)
  • Experience with Software as a Medical Device (SaMD)
  • Experience with Artificial Intelligence/Machine Learning
  • Lead development of quality management systems necessary for compliant software development, validation and verification, especially with respect to AI/ML, including processes for product maintenance and change control management
  • Lead and execute company strategies for all software and AI/ML-based activities for all products and services
  • Partner with regulatory and contribute to software sections of pre-submissions, and other premarket submissions for FDA and other health authorities
  • Work with Freenome team on software quality and validation strategies and their execution, especially in support of AI/ML and software components
  • Provide guidance to Freenome's engineering and automation teams regarding 21 CFR Part 11 compliance
  • Partner with Freenome's regulatory team on FDA policy issues related to AI/ML and digital health
  • Partner with SW Development on establishing SW deliverables in accordance with regulatory requirements and industry best practices
  • Partner with information security on issues regarding cybersecurity
  • Support risk management for software both in pre-market and post market capacity
  • Provide support during inspections and audits, for issues relating to software validation, 21 CFR Part 11 compliance, and other software issues
  • Provide guidance regarding change control management for software embedded in or supporting regulated devices

201-500 employees

Blood test cancer detection biotech company
Company Overview
Freenome's mission is to empower everyone to prevent, detect, and treat disease by developing high-quality diagnostic tests. The developing next-generation blood tests powered by their multiomics platform to discover the body’s earliest warning signs of cancer, and develop accessible tests to detect cancer in its earliest, most treatable stages.
  • Competitive market-based salaries
  • Annual bonus opportunities
  • Relocation packages
  • Medical, dental, & vision coverage
  • 401k
  • Wellness programs
  • Equity
  • PTO
Company Core Values
  • Empathy
  • Integrity
  • Trust
  • Strive for greatness
  • Servant leadership