Associate Director Quality
Associate Director Quality
Posted on :
17-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
17-03-2025
Job Description
About Us
DELFI Diagnostics Inc. (DELFI Diagnostics) is developing nextgeneration bloodbased tests that are reliable accessible and deliver a new way to help detect cancer. Employing advanced machinelearning methods to wholegenome sequencing data the DELFI (DNA EvaLuation of Fragments for early Interception) platform is built to address the highestburden 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 telltale patterns and characteristics of cellfree DNA (cfDNA) fragments. FirstLook Lung for individuals eligible for lung cancer screening is DELFI Diagnostics first laboratorydeveloped 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 lowdose 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 lifechanging 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 highperforming people. Through teamwork we build collective intelligence. Each of us wins when those we serve and those who serve with uswin. We show up with empathy humility and integrity at every step of the journey.
DELFI has 12 designated inoffice 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 youll do
- Develop implement maintain and continuously improve policies and procedures for DELFIs 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 DELFIs 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 crossfunctional 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 youll 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 DELFIs on market LDT product and IVD product development
What youll 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 highperformance results driven team
- Strong interpersonal and communication skills including written and verbal communication and presentation skills
- 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
Preferred
$160000 $195000 a year
Total Compensation at DELFI is a combination of salary bonus equity and benefits. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skillset years & depth of experience certifications & relevant education geography.
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.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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