Twist Bioscience · 1 day ago
Sr Quality Engineer
South San Francisco, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $144K/yr
5+ years expTwist Bioscience is a company that synthesizes genes from scratch, contributing to advancements in genomics. The Sr Quality Engineer is responsible for maintaining the quality management system, conducting risk assessments, and providing technical support to the R&D team to ensure the quality and safety of genomic products and services.
B2BBiotechnologyChemicalHealth CareLife Science
Responsibilities
Maintain a QMS that complies with ISO 13485 and ISO 14971
Conduct risk assessments to identify and assess potential hazards associated with genomic products and services
Develop and implement corrective actions to address identified hazards and prevent recurrence of non-conformities
Provide technical support to the R&D team on quality matters, including design control, process validation, and change control
Conduct audits and inspections to verify compliance with QMS procedures and regulatory requirements
Prepare and maintain quality documentation, including risk management reports, corrective action plans, and audit reports
Stay up-to-date on relevant quality standards and regulations, such as ISO 13485, ISO 14971, and the FDA's Quality System Regulation (QSR)
Lead high visibility complaints and Key customer incidents (Evaluations and Re-Evaluations)
Support Internal and External Audits (FDA, EUIVDR, ISO, Customer, etc.)
Coordinate and participate in Internal Audits
Ensure the Quality Systems group is appropriately staffed to ensure timely completion of responsibilities
Qualification
Required
Bachelor's degree in Engineering, Quality Assurance, or a related field
5+ years of experience in Quality Assurance within the medical device environment
Strong understanding of quality principles and practices, including ISO 13485 and Six Sigma methodologies
Experience in root cause analysis and corrective action implementation
Excellent communication and interpersonal skills, with the ability to interact effectively with technical team members and management
Knowledge of good manufacturing processes
Experience leading and mentoring team members
Experience implementing practical Quality System and Compliance solutions
Benefits
Bonus
Equity
Generous benefits package
Company
Twist Bioscience
Twist Bioscience is a biotechnology company that offers synthetic DNA solutions, gene synthesis, and variant libraries.
501-1000 employees
H1B Sponsorship
Twist Bioscience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (14)
2023 (22)
2022 (19)
2021 (4)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$553.11MKey Investors
Capital World InvestorsBiomatics Capital PartnersIllumina
2022-02-09Post Ipo Equity· $250M
2020-01-27Post Ipo Equity· $50M
2018-10-30IPO
Leadership Team
Emily Leproust
CEO
Siyuan Chen
Chief Technology Officer
Recent News
Genetic Engineering News
2026-01-17
2026-01-16
Company data provided by crunchbase