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Senior Design Quality Engineer

Company: Freenome
Location: San Francisco
Posted on: May 15, 2024

Job Description:

Why join Freenome?
Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. -
Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it's just the beginning. -
Founded in 2014, Freenome has -500 employees and more than $1.1B in funding from key investors, such as the American Cancer Society, Andreessen Horowitz, Anthem Blue Cross, Bain Capital, Colorectal Cancer Alliance, DCVC, Fidelity, Google Ventures, Kaiser Permanente, Novartis, Perceptive Advisors, RA Capital, Roche, Sands Capital, T. Rowe Price, and Verily. - -
At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count. -
Become a Freenomer
Do you have what it takes to be a Freenomer? A "Freenomer" is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients' lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what's possible, one breakthrough at a time.
About this opportunity:
At Freenome, we are seeking a Senior Design Quality Engineer - to help grow the Freenome Quality Assurance team. This person is responsible for implementing and managing Design Control-driven Quality initiatives within Development and Lab Operations. Key responsibilities include, but are not limited to, ensuring Quality in Product Development focused on Next-Generation Sequencing (NGS) and Immunoassay-based assay development, Design Verification & Analytical Validation studies, Risk Management, and Design Transfer activities. You will be engaged in the overall implementation of Quality compliance based on 21 CFR - 820, ISO 13485:2016, ISO 14971:2019, Current Good Manufacturing Practices (cGMPs), in addition to CLIA, CAP and NYSDOH guidelines. - You will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
The role reports to the Senior Director of Quality Assurance.
What you'll do:

  • Partner with Development to ensure implementation of Design Control and Risk Management processes during product development
  • Provide input to support product development as needed
  • Draft Quality SOPs, as needed and as applicable, to Product Development lifecycle
  • Review study protocols and reports for compliance with SOPs and regulations
  • Oversee all aspects of Design Transfer for new assays
  • Lead and take part in Design Reviews and be able to identify risks and gaps which may impact product quality
  • Collaborate with Development, Laboratory Operations, Automation, IT/Software, and Computational Research/Bioinformatics to develop, verify and validate all new processes and methods
  • Lead and participate in dMFEA and pFMEA activities, and maintain and update Risk Management documents
  • Help establish QC processes and Controls in the lab assay workflows
  • Monitor QA activities related to FDA regulations and ISO Standards applicable to Freenome's products
  • Ensure compliance to CAP, CLIA, and NYSDOH requirements for development of Lab Developed Tests (LDT)
  • Support the corporate Quality System

    Must haves:

    • Undergraduate degree in Life Sciences, Biomedical Engineering or equivalent discipline
    • 7+ years of relevant experience in Product Development and/or Quality Assurance in the Medical Device industry, preferably with a focus on In Vitro Diagnostics (IVD)
    • Solid understanding of Design Control, IVD Product Development lifecycle, Analytical and Clinical Validation of IVD products, Risk Management, application of Statistical methods in Development and Operations
    • Familiarity with GxP Regulations, Quality Management Systems (including e-QMS), EDMS, ISO Standards applicable to Medical Devices, CLSI Standards applicable to IVD Product Performance, FDA Regulatory pathways
    • Experience with Project Management and presentation tools
    • Ability to work effectively in a collaborative team environment where results are achieved through incorporation of multiple points of view
    • Ability to adapt in a fast-paced, dynamic environment and manage multiple competing priorities with aggressive timelines
    • Track record of strong execution and delivering results
    • Attention to detail and commitment to Quality at every stage of the product life cycle
    • Self-driven with the ability to work under minimal supervision and strong desire to further develop professionally through peer feedback
    • Excellent written and verbal communication
    • Critical and analytical thinking, ability to assess risks and benefits, come up with creative solutions

      Nice to haves:

      • Masters degree preferred
      • Quality Certifications (e.g., CQA, CMQ/OE, Six Sigma, ISO 13485 Lead Auditor, etc.) highly desirable

        Benefits and additional information:
        The US target range of our base salary for new hires is $128,000 - $195,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ - for additional company information. - -
        Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
        Applicants have rights under Federal Employment Laws. - -

        • Family & Medical Leave Act (FMLA)
        • Equal Employment Opportunity (EEO)
        • Employee Polygraph Protection Act (EPPA)


Keywords: Freenome, San Francisco , Senior Design Quality Engineer, Engineering , San Francisco, California

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