About Us
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.
Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class
Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.
DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices
In this role, you will develop, implement, execute, maintain, and lead Quality Systems activities related to DELFI Diagnostics’ Quality Management System (QMS). You will provide oversight of the QMS to ensure compliance and effective processes are maintained per applicable regulatory requirements and company procedures. This role will build and lead continuous improvements to the QMS to support IVD activities and infrastructure.
What you'll do
Develop, implement, maintain, and continuously improve policies and procedures for DELFI’s QMS to ensure compliance with all applicable requirements including FDA 21 CFR Part 820, ISO 13485, CLIA, CAP, NYSDOH, and GCP
Lead and own a number of key Quality System Elements for DELFI’s QMS including but not limited to the following: Design Quality, Internal and External audits, Nonconformance Handling, Corrective Action Preventive Action (CAPA), Complaint Handling, Management Review, Supplier Quality, Risk Management, Change Management, Document Control, Training, and Record Management from implementation to maintenance
Oversee day to day Quality work for the organization and provide guidance to ensure compliance and effective processes are maintained
Support cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
Provide support and assistance to cross functional teams to drive inspection readiness activities and support regulatory authority inspections
Lead organizational compliance to all applicable regulatory and company procedures by providing continuous guidance, training, and education
What you'll have accomplished 12 months from now
You will have participated in the implementation and maintenance of the DELFI QMS that is compliant to FDA 21 CFR 820, CLIA, CAP, NYSDOH, ISO, and GCP requirements to support DELFI’s on market LDT product and IVD product development
What you'll bring to DELFI
BS Required (in Science, Engineering, or equivalent)
10+ years of total experience in Quality with a 7 years supporting IVD medical device design and development
Advanced working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971 and related medical device regulations and standards
Experience leading inspection readiness activities and coordinating regulatory agency inspections
Experience with conducting audits as a lead auditor
Demonstrated strategic and tactical leadership building a high-performance results driven team
Strong interpersonal and communication skills, including written and verbal communication, and presentation skills
Preferred
Previous experience supporting LDT laboratories and proficient with CAP/CLIA standards and regulations
Ability to influence, build, and foster relationships horizontally and vertically across the organization
Certified Lead Auditor
Ability to address and resolve a variety of complex issues diplomatically
Molecular diagnostics background
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.
