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Quality Assurance Associate

Ozette Technologies

Ozette Technologies

Quality Assurance
Posted on Thursday, October 5, 2023

About Us 

Each year people are diagnosed with cancer, autoimmune diseases, chronic conditions, and more. The immune system is the ultimate determinant of health and disease; however, it remains a black box. Leveraging our AI-first technology, we want to provide high-resolution understandings of the immune system to fully unlock its power. And with your help, we can do it.  

From technology built and proven at Fred Hutch, Ozette is creating a revolutionary immune profiling platform to turn high-dimensional single-cell data into actionable insights. Enhancing insights by 10-fold in volume and resolution—scientists, clinicians and our teams—will accelerate breakthroughs to drive better patient outcomes. Our founders are leading experts in data science, computational biology, and medicine and we are backed by some of the best technology investors, including Madrona Venture Group (first investors in Amazon), Microsoft cofounder Paul Allen’s Institute for Artificial Intelligence, and Vulcan Capital. 

At the heart of great companies are great teams. We strive to give you everything you need to thrive at work and beyond, including top medical, dental and vision benefits, and 401(k). We offer full benefits, hybrid office schedule, honor all 11 federal holidays + an added extra day off for every holiday, plan company-wide respites during Thanksgiving, Xmas and New Year's, and offer a 'take what you need' vacation policy. If you’re passionate about leveraging technology to improve health, explore joining our innovative, creative team. 


Quality Assurance Associate Responsibilities

  • Support management of the electronic Quality Management System (eQMS) and document control
  • Initiate new employee onboarding training and monitor employee training
  • Support the audit program by assisting external audits/inspections, performing internal process audits, and reviewing external requests for information (RFIs)
  • Track and ensure proper triage, completion, and closure of quality records such as nonconformances, deviations, CAPAs, and change controls
  • Participate in the feedback and complaint handling process
  • Manage the Supplier Qualification program including approving supplier evaluations and performing supplier audits as needed
  • Review and approve Analytical Plans and as needed, Data Transfer Agreements for clinical trial studies
  • Track metrics used for annual quality management and software periodic reviews
  • Represent Quality in cross-functional team meetings and project manage, where necessary


About You   

  • Demonstrated knowledge of GxP, FDA, medical device software regulations and guidances, and international standards applicable to handling and testing of clinical trial samples, associated data, and software medical devices
  • Experience with software (SDLC), equipment (IQOQPQ), and assay validation preferred
  • Ability to work in a high paced collaborative team environments, meet deadlines, and prioritize work from multiple highly complex projects
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
  • Familiarity in Lean, Six Sigma and risk management concepts and tools preferred


Our Commitment  

At Ozette, we embrace and celebrate individuality. We know that our work and our teams thrive most when we are diverse and inclusive, so we take equal opportunity seriously. We commit to fostering a respectful, diverse, and inclusive environment where all team members can contribute and develop to their fullest potential. We welcome individuals of all backgrounds, orientations, and identities to join our community. 

Base salary range: $80,000-$115,000 USD

Total compensation, which includes equity, determined based on experience.