Head of Quality Assurance

4 weeks ago

Redwood City, California, United States Tesseract Health Full time
Join Our Mission to Revolutionize Healthcare

We're a pioneering health-tech company, identifeye HEALTH Inc., on a mission to democratize access to health information. Our innovative approach combines laboratory medicine and radiology to enable non-invasive health monitoring for ocular and systemic diseases. We believe in empowering individuals with approachable and intuitive products that provide personalized health insights.

Our Culture
  • Prioritize the Patient: We create products that remove barriers between quality care and those who need it.
  • Data-Driven Decisions: We seek the best solutions, backed by data, and optimized for speed, simplicity, and scale.
  • Support Each Other: We celebrate ideas and contributions, recognizing that we succeed as a team.
  • Simplify: We build intuitive solutions to simplify patient care.
The Role

The Head of Quality will play a pivotal role in ensuring our medical devices and processes meet FDA regulatory and international requirements, safeguarding patient safety and compliance. Key responsibilities include:

  • Leading the Quality Assurance team, providing coaching, mentorship, and development opportunities.
  • Managing the Quality Management System (QMS), authoring, reviewing, and approving changes.
  • Developing, writing, maintaining, administering, and providing training on quality systems documents and procedures.
  • Managing and improving the internal training program to ensure quality awareness and regulatory compliance knowledge.
  • Leading the company's ISO and FDA compliance efforts, particularly in risk management, SDLC, and design control.
  • Ensuring the proper integration of QARA procedures and processes within product development, clinical, manufacturing, supply chain, and other relevant departments.
  • Monitoring regulatory updates and driving necessary training and procedure/process changes to maintain compliance.
  • Assisting in the preparation of regulatory submission documents and supporting interactions with regulatory agencies.
  • Supporting the development of global regulatory strategies for the introduction of new and modified device platforms.
  • Leading and managing quality system audits, including internal audits and external audits.
  • Representing QARA as the management representative and demonstrating leadership in Management Reviews, Audits, CAPAs, and related compliance activities.
  • Identifying and communicating risks and mitigation strategies associated with quality/regulatory strategies.
What We're Looking For
  • Bachelor's degree in life sciences, engineering, or a related discipline.
  • 12+ years of progressive experience in quality assurance and regulatory affairs.
  • Experience in building, improving, and maintaining FDA and ISO compliant quality management systems.
  • Knowledge and experience with relevant standards: ISO 9001, ISO 13485, IEC 62304, ISO 14971, and 21 CFR 820 (FDA cGMP/QSR).
  • Prior experience with submission of regulatory filings and correspondence with regulatory bodies.
  • Strong understanding of advanced QARA systems, including the establishment of relevant QARA metrics to track performance and compliance.
  • Entrepreneurial, innovative, energetic, hands-on, team-oriented, and customer-focused, with the ability to think strategically and execute project details.
What We Offer
  • Anticipated salary range: $170,000 to $210,000 annually.
  • Annual bonuses, equity, and program-specific awards.
  • Fully covered medical insurance plan, dental, and vision coverage.
  • 401(k) plan.
  • Flexible PTO policy and remote/hybrid work arrangements.
  • Free onsite meals and kitchen stocked with snacks.
  • Annual Improve Your Work Environment stipend.
  • Professional development reimbursement.

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