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.
San Francisco Bay Area Pay Range
$150,000—$175,000 USD
