Sr Quality Engineer at Twist Bioscience

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Medical DeviceIndustries

Requirements

Bachelor's degree in Engineering, Quality Assurance, or a related field
5+ years of experience in complaint handling, preferably in a genomics or medical device environment
Stay up-to-date on relevant quality standards and regulations, such as ISO 13485, ISO 14971, and the FDA's Quality System Regulation (QSR)
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 customers, technical team members, and management
Knowledge of good manufacturing processes
Experience leading and mentoring team members
Experience making trade-off decisions while balancing compliance and business impact
Experience working in cross functional teams
Experience implementing practical Quality System and Compliance solutions

Responsibilities

Implement and 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
Lead internal CAPAs related to Supplier Controls
Lead high visibility complaints and Key customer incidents (Evaluations and Re-Evaluations)
Support Internal and External Audits (FDA, EUIVDR, ISO, Customer, etc.) representing Supplier Quality in Audits Front rooms
Coordinate and participate in Internal Audits in addition to Supplier Audits
Ensure the Quality Systems group is appropriately staffed to ensure timely completion of responsibilities

Skills

ISO 13485

ISO 14971

Risk Assessment

CAPA

Complaint Handling

Supplier Quality

Internal Audits

FDA QSR

Design Control

Process Validation

Change Control

EUIVDR

Twist Bioscience

Produces synthetic DNA for biotechnology applications

About Twist Bioscience

Twist Bioscience specializes in creating synthetic DNA for applications in biotechnology, pharmaceuticals, and research. Their proprietary platform allows for the quick and accurate production of DNA sequences, providing clients with products like genes, oligo pools, and variant libraries. The company stands out by offering high-quality DNA at competitive prices, making them a valuable partner for academic institutions and pharmaceutical companies. Twist Bioscience aims to support advancements in personalized medicine and biotechnology through their innovative DNA synthesis solutions.

South San Francisco, CaliforniaHeadquarters

2013Year Founded

$236.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

401(k) Retirement Plan

Risks

Increased competition from Ginkgo Bioworks may impact Twist's market share.

Dependency on AI technologies could pose integration and operational challenges.

New CIO appointment may lead to transitional challenges in IT strategy and operations.

Differentiation

Twist Bioscience uses a unique silicon-based DNA synthesis platform for precision and scale.

They offer high-quality DNA sequences at competitive prices, attracting diverse clients.

Their proprietary platform provides instant feedback on DNA sequence synthesis feasibility.

Upsides

Growing demand for synthetic DNA in personalized medicine boosts Twist's market potential.

Collaboration with Absci leverages AI to accelerate antibody discovery and drug development.

Synthetic biology market projected to grow at 28.8% CAGR, benefiting Twist's growth.

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