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Palo Alto, California, United States
Onsite
23andMe is looking for a Quality Engineer to join our Regulatory Affairs / Quality Assurance team. You will work closely with our Customer Care and Laboratory Operations teams to investigate quality complaints, and will also work with our Product and Engineering teams to define, document, and verify quality requirements for new projects. You will also be responsible for 23andMe’s Personal Genome Service Post-Market Surveillance Program.
Who We Are
We are a group of individuals passionate about genetic discovery. 23andMe Research Institute is a nonprofit medical research organization that enables people everywhere to access their genetic information, learn about themselves, and participate in the world's largest crowdsourced research initiative. The Institute aims to be the world's most significant contributor to scientific advancement, uniting people with the common goal of improving health and deepening our understanding of DNA — the code of life.
What You'll Do
Lead Post-Market Surveillance (PMS) activities.
Investigate quality complaints with a cross-functional team and perform customer risk assessments and regulatory reportability determinations.
Calculate defect rates and prepare monthly defect reports/ quarterly scorecards for critical suppliers.
Participate in product development teams as the Quality Assurance/ Regulatory Affairs representative. Assess the impact of new projects on the Design History File (DHF) and manage design changes accordingly.
Thoroughly document change management records.
Maintain and develop standard operating procedures (SOPs) to implement effective and agile complaint handling, change management, and design control processes.
Investigate nonconformances and manage corrective actions relating to the complaints, change management, or design control quality system processes.
Participate in the continuous improvement of the Veeva electronic quality system.
What You’ll Bring
Minimum of a Bachelor's degree in a relevant scientific or engineering discipline. Advanced degree preferred.
3+ years of Quality Assurance / Regulatory Affairs experience in medical devices or CLIA-certified laboratories.
Thorough understanding of and experience working with 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and MDR/IVDR requirements.
Demonstrated ability to identify and articulate risk to product quality and processes. Proficiency in risk analysis tools and techniques (e.g. FMEA).
Experience with design controls for laboratory equipment/ assays/ software.
Tenacious attention to detail and consistency.
Ability to work independently with minimum supervision.
Ability to prioritize and multitask. Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative attitude.
Ability to work from 23andMe's office in Palo Alto, CA a minimum of 3 days per week.
Strongly Preferred
Experience in medical device Regulatory Affairs (RA), especially supporting Q-Sub or 510(k) submission.
American Society for Quality (ASQ) Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) or Certified Medical Device Auditor (CMDA).
Direct experience participating in and supporting internal and external audits.
Familiarity with LLM tools (Gemini, Claude, NotebookLM, Github Copilot).
About Us
23andMe, headquartered in California, is a leading consumer genetics and research company. 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. 23andMe research participants consent to research conducted by 23andMe which is overseen by an independent third-party Institutional Review Board (IRB) regulated under the 'Common Rule' (45 CFR part 46). More information is available at www.23andme.com/research.
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.
Pay Transparency
23andMe takes a market-based approach to pay, and amounts will vary depending on your geographic location. The salary range reflected here is for a candidate based in the San Francisco Bay Area. The successful candidate’s starting pay will be determined based on job-related skills, experience, qualifications, work location, and market conditions. These ranges may be modified in the future.
San Francisco Bay Area Base Pay Range
$110,000-$160,000