Sr. Supplier Quality Specialist II

The Sr. Supplier Quality Specialist is an integral member of the Supplier Quality team, whose primary role is to ensure that quality system requirements are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, ISO 14971, CAP, CLIA and other regulations worldwide as applicable. In this role you will facilitate the supplier compliance program (site inspections, drive improvement in supplier performance, supplier development, supplier selection and qualification). 

Who We Are

Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.

What You’ll Do

• Evaluate and qualify new suppliers
• Create, revise and maintain supplier quality standard operating procedures
• Create and maintain supplier quality agreements
• Maintain the approved supplier list, supplier scorecard, and supplier audit schedule 
• Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
• Conduct quality system audits of suppliers to identify potential areas of risks and drive continuous improvement
• Investigate customer complaints and audit findings, gather and analyze data to determine root cause and implement corrective action to reduce or eliminate cause
• Actively monitor supplier quality metrics, quality agreements with critical suppliers, and quality of supplier records 
• Actively participates in supplier quality related communication and feedback

What You’ll Bring

• Minimum of a Bachelor's degree in a life science is required (genetics or molecular biology preferred)
• Clinical Laboratory certification (California CLS licensure or similar) 
• ISO 13485 certified Lead Auditor
• Proven track record in root cause analysis, corrective and preventive action methods
• Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why’s, Pareto Analysis, Six Sigma
• Experience with internal audits or external audits
• Current working knowledge of 21 CFR 820, ISO 13485, ISO 14971, CAP and CLIA regulations preferred
• Problem solving skills and the ability to appropriately evaluate a situation and prioritize factors for decision making
• Understanding of project management (experience preferred)
• Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems
• Must be able to write clear, understandable technical documents
• Ability to compile data and summarize results
• Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation and style
• Ability to prioritize and multi-task while maintaining a positive and collaborative attitude
• Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
• Flexibility to support changing assignments and priorities in an independent and reliable manner
• Travel 0 - 10%

About Us

23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.

At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state