Quality Engineer

23andMe

Palo Alto, CA, US
San francisco bay area base pyy range: $110,000-$1...
On-site (minimum 3 days a week in palo alto, ca)
Investigate quality complaints
Post-market surveillance
Design history file (dhf)
23andMe is seeking a Quality Engineer to support their Regulatory Affairs and Quality Assurance team, focusing on quality complaints and post-market surveillance. The ideal candidate should have a strong background in quality assurance within medical devices or CLIA-certified labs, along with relevant regulatory experience

Job Summary

  • 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.
  • Lead Post-Market Surveillance (PMS) activities and investigate quality complaints with a cross-functional team, performing customer risk assessments and regulatory reportability determinations.
  • Maintain and develop standard operating procedures (SOPs) to implement effective and agile complaint handling, change management, and design control processes.

Matching Summary

Match Score: 85

23andMe is seeking a Quality Engineer to support their Regulatory Affairs and Quality Assurance team, focusing on quality complaints and post-market surveillance. The ideal candidate should have a strong background in quality assurance within medical devices or CLIA-certified labs, along with relevant regulatory experience.

Salary

San Francisco Bay Area Base Pay Range: $110,000-$160,000

Skills & Requirements

Must-have

  • Investigate quality complaints
  • Post-Market Surveillance
  • Design History File (DHF)
  • Standard Operating Procedures (SOPs)
  • Corrective actions

Nice-to-have

  • Continuous improvement
  • Agile complaint handling
  • Positive and collaborative attitude

Key Requirements

  • Bachelor's degree in relevant discipline
  • 3+ years QA/RA experience
  • Experience with 21 CFR 820, ISO 13485
  • Experience with IEC 62304, ISO 14971
  • Experience with MDR/IVDR requirements
  • Proficiency in risk analysis tools (FMEA)
  • Experience with design controls

Work Rights

Not specified

Tailored Resume

Cover Letter