Twist Bioscience
Manager, Quality Management Systems
USA - South San Francisco, CA · Senior
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About the role
- About Twist Bioscience Twist Bioscience synthesizes genes from scratch, known as "writing" DNA.
Responsibilities
- 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.
- Support the product and software development lifecycles with appropriate design controls.
- Maintain monitoring and measurement systems and drive continuous improvement.
- Proven experience developing and implementing QMS procedures and conducting internal and external audits.
- 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.
Requirements
- Hands-on experience with QMS management software.
- Experience with the product development lifecycle and product commercialization, including guiding large-scale programs toward commercialization goals.
- The ideal candidate brings deep ISO 13485 expertise, hands-on audit experience, and a strong understanding of the genomics or life sciences space.
Nice to have
- Experience in the genomics industry.
- Experience with EU IVDR.
- Experience with GMP requirements.
- 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.
- Twist Bioscience Corporation is an Equal Opportunity Employer.
Compensation
- San Francisco Bay Area Pay Range
Benefits
- 7+ years of experience in the medical device or biotechnology industry, with a strong focus on QMS and ISO 13485 compliance.
Company info
- 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.
- We are looking for an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485-certified QMS.
This listing is sourced directly from Twist Bioscience's careers page and normalized into a canonical job model.