QMS Director: ISO 13485, Audits & Training Leader

Regulatory Jobs; South San Francisco (CA); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Bonus

Equity

Generous benefits

Job summary

Twist Bioscience is seeking an experienced Manager of Quality Management Systems to build, maintain, and improve an ISO 13485-certified QMS. You will own the internal and external audit program, manage the audit team, and lead the quality training program across all disciplines.

The role requires deep ISO 13485 expertise and hands-on audit experience in genomics or life sciences. You will design and maintain quality programs that meet customer requirements for each product line, support

Qualifications

• Bachelor’s degree in Engineering or Life Sciences or related field.
• 7+ years of experience in medical device/biotech quality management.
• Proven experience in developing and implementing QMS procedures and conducting audits.
• Strong knowledge of ISO 13485, genomics, regulatory compliance.

Responsibilities

• Implement and maintain QMS procedures compliant with ISO 13485:2016 and regulations.
• Own internal and external audit program and resolve nonconformities.
• Lead quality training program including curriculum and tracking.
• Oversee supplier quality objectives and design controls support.
• Drive continuous improvement across monitoring systems and product lifecycles.

Skills

ISO 13485

QA Management

Audits

Regulatory compliance

Leadership

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s preferred

Tools

QMS software

Job description

Twist Bioscience is seeking an experienced Manager of Quality Management Systems to build, maintain, and improve an ISO 13485-certified QMS. You will own the internal and external audit program, manage the audit team, and lead the quality training program across all disciplines.

The role requires deep ISO 13485 expertise and hands-on audit experience in genomics or life sciences. You will design and maintain quality programs that meet customer requirements for each product line, support