About this opportunity:
The Supplier Quality Specialist III/IV 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 this role you will facilitate the supplier compliance program (external audits, drive improvement in supplier performance, supplier development, supplier selection and qualification). In addition, this role will support the quality assurance activities in partner development as needed.
What you’ll do:
- Maintain the approved supplier list and supplier audit schedule
- Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
- Conduct external and internal quality audits to identify potential areas of risks and drive continuous improvement
- Lead establishing quality agreements with critical suppliers, and quality of supplier records
- Actively participate in supplier quality related communication and feedback.
- Lead the processing of supplier change notifications
- Engage directly with Freenome suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received
- Maintain supplier non-conformances to closure and effectiveness review, working with impacted departments
- Maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
- Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.
Must haves:
- Minimum of a Bachelor's degree in a life science field (genetics or molecular biology preferred) or equivalent experience
- 5+ years of experience in manufacturing operations, clinical laboratory operations, quality, or supplier quality
- ISO 13485 certified Lead Auditor or Certified Quality Auditor (CQA)
- Effective problem solving skills and ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
- Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems
- Ability to prioritize and multitask while maintaining a positive and collaborative attitude
- Experience with both internal audits or external audits
- Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
- Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
- Flexibility to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Drive for results and continual improvement
- Travel 10 - 30% domestically and potentially internationally, potentially more as needed
Nice to haves:
- Certified Quality Engineer, CQE (ASQ)
- Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis, Six Sigma
- Experience with statistical process control (SPC) techniques to evaluate and improve process performance
- Experience with process validations
Additional information:
Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ 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)
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Skills Required
- Minimum of a Bachelor's degree in a life science field
- 5+ years of experience in manufacturing operations or quality
- ISO 13485 certified Lead Auditor
- Effective problem solving skills
- Proficiency in Word, Excel, PowerPoint
- Experience with document management systems
- Effective verbal and written communication skills
- Effective teamwork skills
- Drive for results and continual improvement
- Travel 10 - 30% domestically or internationally
What We Do
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.
