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.
