Senior Quality Engineer
2 weeks ago
Join our elite Quality Assurance and Regulatory Affairs (QARA) team at BillionToOne, a top-notch startup recognized among the top 5% of Y Combinator companies with substantial funding. Our groundbreaking technology, UNITYTM, is leading the way in non-invasive prenatal testing, offering a comprehensive analysis of an unborn baby's health with a simple blood sample from the mother.
At BillionToOne, we are dedicated to revolutionizing oncology treatment with innovative liquid biopsy products that can tailor therapy based on individual genetic profiles. As we continue to grow, we are seeking a proactive Senior Quality Engineer to drive excellence in our products and services.
Responsibilities:
- Conduct statistical analysis to improve quality initiatives.
- Implement corrective actions to enhance product quality.
- Collaborate with diverse teams for process enhancement.
- Maintain quality documentation and provide training.
- Ensure compliance with regulatory standards.
- Stay informed about industry trends and best practices.
- Bachelor's degree in a relevant field; advanced degree preferred.
- Minimum 5 years' experience in the industry.
- Expertise in lab practices, bioinformatics, and quality tools.
- Strong knowledge of regulatory requirements.
- Ability to drive results and facilitate change.
- Experience with ISO13485 and FDA CFR a plus.
- Collaborative and transparent work culture.
- Opportunity to impact healthcare outcomes positively.
- Comprehensive medical benefits and generous parental leave.
- Retirement savings program and on-site perks.
- Competitive salary range with equity options.
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