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About the Role
We are seeking an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485-certified QMS. This role involves owning our internal and external audit program and quality training program, ensuring QMS compliance, and supporting regulatory initiatives. The ideal candidate possesses deep ISO 13485 expertise, hands-on audit experience, and a strong understanding of the genomics or life sciences sector.
Responsibilities
- Implement and maintain QMS procedures compliant with ISO 13485:2016 and other applicable regulations.
- Support certification across product lines.
- Own the internal and external audit program, including scheduling, conducting audits, and resolving nonconformities.
- Manage the local and global audit team.
- Own the quality training program, including curriculum development, assignments, and completion tracking.
- Lead Quality Assurance initiatives and projects focused 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 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.
Requirements
- 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.
- 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.
Skills
- ISO 13485
- QMS
- Auditing
- Quality Training
- Regulatory Compliance
- Genomics
- Life Sciences
- Product Development Lifecycle
- Design Controls
- Risk Management
- FDA Regulations
- IVD
- EU IVDR
- GMP
- Six Sigma
Location
- California
- San Francisco Bay Area
Work Type
- Full-time
Experience Level
- Manager
- 7+ years
Education Level
- Bachelor's degree
- Master's degree
Salary/Compensations
- $150,000—$175,000 USD
Benefits
- Bonus
- Equity
- Generous benefits package
About the Company
- Twist Bioscience synthesizes genes from scratch, known as “writing” DNA.
- We work in service of people who are changing the world for the better.
- Our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers in fields such as health care, agriculture, industrial chemicals, and data storage.
Equal Opportunity
- 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.