Senior QMS Lead – ISO 13485, Audits & Training

Twist Bioscience Corporation; San Francisco (CA); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Bonus eligibility

Equity

Generous benefits package

Job summary

Twist Bioscience Corporation seeks an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485‑certified QMS. You will own our internal and external audit program and our quality training program, ensuring compliance across all disciplines and supporting regulatory initiatives.

You will design quality programs to meet customer requirements for each product line and mentor QA staff in ISO 13485 and regulatory practices.

Qualifications

• Experience implementing and maintaining ISO 13485‑compliant QMS.
• Proven ability to conduct internal and external audits.
• Experience managing audit programs locally and globally.
• Strong regulatory knowledge in genomics and life sciences.
• Hands-on experience with QMS software.

Responsibilities

• Implement and maintain QMS procedures compliant with ISO 13485 and regulations.
• Own the internal and external audit program, schedule audits, and resolve nonconformities.
• Manage the local and global audit team.
• Own the quality training program, including curriculum development and tracking.
• Lead QA initiatives on audit, training, and compliance.
• Oversee QMS compliance for all personnel and functions.
• Ensure supplier quality objectives are met.
• Support product and software development lifecycles with design controls.
• Maintain monitoring and measurement systems and drive continuous improvement.
• Train and mentor QA team members on QMS and regulatory compliance.
• Stay current on industry trends and regulatory changes in genomics.

Skills

Leadership

Communication

Problem-solving

Analytical skills

Teamwork

Independent work

Regulatory awareness

Education

Bachelor’s degree in Engineering, Physical/Life Sciences, or related field

Master’s degree preferred

7+ years in medical device/biotech with QMS/ISO13485

Tools

QMS management software

Job description

Twist Bioscience Corporation seeks an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485‑certified QMS. You will own our internal and external audit program and our quality training program, ensuring compliance across all disciplines and supporting regulatory initiatives.

You will design quality programs to meet customer requirements for each product line and mentor QA staff in ISO 13485 and regulatory practices.