Facebook pixel

Director – Software Quality
Posted on 11/26/2022
INACTIVE
Locations
San Bruno, CA, USA • Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Requirements
  • 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
Responsibilities
  • 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
Freenome

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.
Benefits
  • 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