Senior Supplier Quality Specialist/Engineer

The Senior Supplier Quality Specialist role plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation 21 CFR § 820 and ISO 13485 as well as CLIA, CAP, and applicable state requirements.  In addition, this role will support the quality assurance activities in partner development due diligence and both internal and external audits.  

How you’ll contribute:

• Build solid relationships with supplier quality teams to ensure Freenome goals and objectives are met with supplies and services.
• Responsible for the Supplier Quality program initiation, in partnership with relevant departments, including supplier selection, qualification, and management
• Work with Development and Quality (NPI team) to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in developing inspection methods and improving sampling plans for new materials and components.
• Work with the Clinical Quality team to support supplier qualification for clinical suppliers as needed, included and not limited to aligning the process as needed.
• Collaborate with Supply Chain to assess current suppliers and support selection of best-in-class suppliers
• Perform supplier quality audits to ensure that Freenome continuously receives high quality product and services, with limited travel at this time
• Negotiate and maintain supplier quality agreements with key suppliers
• Evaluation of supplier change notifications for impact to Freenome
• Develop key supplier quality metrics and engage directly with the suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received 
• Manage all supplier non-conformances to closure and effectiveness review, working with impacted departments
• Prepare and support business development and commercial teams with partner due diligence activities and audits
• Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
• Represent Quality at cross functional meetings
• Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.

What you’ll bring: 

• Bachelor’s degree in engineering, biology or a related scientific discipline
• Certified Auditor or Certified Quality Professional preferred
• 5+ years of supplier quality experience, with prior experience in an FDA regulated Medical device environment, in vitro diagnostics or a CAP/CLIA laboratory preferred
• Working knowledge of medical device / in vitro diagnostic (IVD) regulations (e.g., FDA 21 CFR § 820, ISO 13485, IVDR, ISO 15189, CAP/CLIA and other applicable quality and regulatory standards)
• Experience in all aspects of supplier quality, including supplier assessments/audits, maintaining a supplier evaluation program, supplier corrective actions and supplier process changes
• Previous experience with the entire quality agreement process
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
• Ability to constructively challenge concerns and engage in transparent conversations
• Ability to work effectively in a team environment
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
• Proven attention to detail and accuracy
• Effective organizational skills
• High degree of initiative and self-motivation
• Drive for results and continual improvement – Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement

Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.

About Freenome

Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.

We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw.  By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science. 

Our recent $270 Million Series C brings our financing to over $500 million from investors, including;  Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences. 

Our Science

Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure. 

By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.  

Our Culture

Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve.  We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives.  We believe in empowering and supporting each other in a collaborative and dynamic environment. 

What does a successful person look like at Freenome?

Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.