Manager, Quality Management Systems

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

We are looking for an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485-certified QMS. In this role, you will own our internal and external audit program and our quality training program. You will keep the QMS compliant across all disciplines and support regulatory initiatives. You will also design and maintain quality programs that meet customer requirements for each product line.The ideal candidate brings deep ISO 13485 expertise, hands‑on audit experience, and a strong understanding of the genomics or life sciences space.

What You’ll Do

• Implement and maintain QMS procedures that comply with ISO 13485:2016 and other applicable regulations, and support certification across product lines.
• Own the internal and external audit program. This includes setting the audit schedule, conducting audits, and identifying and resolving nonconformities.
• Manage the local and global audit team.
• Own the quality training program, including curriculum development, training assignments, and completion tracking across all disciplines.
• Lead Quality Assurance initiatives and projects focused on audit, training, and compliance.
• Oversee QMS compliance for all personnel and functions.
• Make sure supplier quality objectives are met.
• Support the product and software development lifecycles with appropriate design controls.
• Maintain monitoring and measurement systems and drive continuous improvement.
• Train and mentor QA team members on QMS principles, ISO 13485, and regulatory compliance.
• Stay current on industry trends and regulatory changes in genomics.

What You’ll Bring

• Bachelor’s degree in Engineering, Physical/Life Sciences, or a related field (Master’s preferred).
• 7+ years of experience in the medical device or biotechnology industry, with a strong focus on QMS and ISO 13485 compliance.
• Proven experience developing and implementing QMS procedures and conducting internal and external audits.
• Working knowledge of ISO 13485, genomics, and regulatory compliance.
• Hands‑on experience with QMS management software.
• Experience with the product development lifecycle and product commercialization, including guiding large‑scale programs toward commercialization goals.
• Strong supervisory, organizational, analytical, and problem‑solving skills.
• Excellent written and verbal communication, collaboration, and leadership skills.
• Ability to work independently and on a team in a fast‑paced environment.

Nice to Have

• Experience in the genomics industry.
• Experience with FDA regulations for medical devices and IVDs.
• Experience with EU IVDR.
• Experience with GMP requirements.
• Deep knowledge of risk management and design controls.
• Six Sigma or other quality improvement methodology experience.

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 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.

The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations.

$150,000 - $175,000 USD