Quality Engineer

23andMe Research Institute • Palo Alto, CA

1d • $110,000 - $160,000 • Onsite

About The Position

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.

Requirements

• Minimum of a Bachelor's degree in a relevant scientific or engineering discipline.
• 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.

Nice To Haves

• Advanced degree 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).

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level