Twist Bioscience · 4 days ago
Quality Engineer
Portland, OR
Full-time
Hybrid
Mid Level
3+ years expTwist Bioscience is a company focused on providing innovative solutions in the biotechnology industry. The Quality Engineer will support product quality throughout the product life cycle, ensuring compliance with regulatory requirements and contributing to quality control procedures.
B2BBiotechnologyChemicalHealth CareLife Science
Responsibilities
Conduct comprehensive reviews of batch records to ensure compliance with cGMPs and company procedures
Identify and investigate potential discrepancies or anomalies in batch records
Perform statistical analyses on batch data to assess product quality and identify trends
Prepare and maintain statistical reports to document findings and support quality decision-making
Contribute to the development and implementation of quality control procedures
Participate in product release activities, including reviewing release documentation and providing quality assurance sign-off
Stay up-to-date on the latest cGMP regulations and quality engineering practices
Provide quality support to quality control, field application scientists, and customer support
Provide support to design and development, engineering, and manufacturing for functions for validation planning and transfer activities
Collaborates with Quality Management to support change controls activities (e.g. engineering, process, raw materials, etc.) deviation management, and document change management
Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective/preventive actions
Represents QA and QC on the incident management committee in efficiently processing customer incident and identifying trends to help improve product quality
Provides quality support in the assessment and qualification of new supplier materials such as component specifications and inspection standards
Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change requests
Provide quality consultation to end users and process owners with regards to data collection, analysis, and creation of validation reports
Become familiar with the applicable technology to facility ate participation in technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for compliance to internal quality requirements
Coordinate issue resolution using risk-based approach
Identify areas and opportunities to improve quality system processes and product issues
Ensure product development and validation programs meet internal quality programs
Trend, analyze, and report on quality data in order to improve product and processes
Provide management with status updates on assigned responsibilities and goals
Escalate issues in a timely fashion
Own and/or coordinate CAPAs, Complaints, and NCRs specific to product quality issues
Effectively influences and trains employees (as required)
Maintains strong communication network with peers
Demonstrated effective knowledge of use of various computer systems
Additional responsibilities as assigned
Ability to travel 10%
Follow regulatory and ISO 13485 requirements
Qualification
Required
Bachelor's degree in a scientific or engineering discipline, plus a minimum 3 years of work experience in quality engineering role; or equivalent work required
Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, IVDR, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP
Highly organized, with ability to prioritize own tasks and ability to work effectively virtually in conducting internal and external business
Strong interpersonal skills
Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/information
Ability to work across functions throughout a global organization at all levels
Preferred
Experience in Pharmaceutical, NGS, and/or Molecular Diagnostics a plus
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