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Regulatory Affairs

Supplier Quality Specialist

Sunnyvale, California, United States

In this role as  Supplier Quality Specialist, you will be an integral member of the Supplier Quality team. This team ensures 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 support the supplier compliance program by participating in activities such as site inspections, driving improvement in supplier performance, supplier development, and 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

  • Create, revise and maintain supplier quality standard operating procedures
  • Assist in the evaluation and qualification of new suppliers
  • Maintain the approved supplier list, supplier scorecards, supplier audit schedule and supplier files 
  • Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
  • Support 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 participate in supplier quality related communication and feedback

 

What You’ll Bring

Education: 

  • A Bachelor's degree in a life science is required (genetics or molecular biology preferred)

Experience: 

  • Minimum of 1-3 years of experience in a Quality Assurance role including experience in Supplier Quality
  • Working knowledge of root cause analysis, corrective and preventive action methods
  • Familiarity with quality system methodologies including but not limited to Lean, 5 Why’s, Pareto Analysis, Six Sigma 
  • Experience with internal audits and/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, 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 or local laws.  If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at accommodations-ext@23andme.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.

Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.

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