The Sr Quality Engineer is responsible for ensuring the quality and safety of our genomic products and services by assisting in the maintenance of the quality management system (QMS) that complies with ISO 13485 and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support to the R&D team.

What You’ll Be Doing

• 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.

What You’ll Bring to the Team

• 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. 

About Twist Bioscience

Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.

At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.

Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.