New · posted Oct 15
Twist Bioscience · Biotechnology
Manager, Quality Management Systems
- South San Francisco, CA
- On-site
- Full-time
- Manager
Open until filled
The role
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.
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.
What you need
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 Havenice 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.
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.
Pay and benefits
$150,000 – $175,000 a year
Employer providedBonus eligibility
Equity eligibility
Generous benefits package
Where you'll work
South San Francisco, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAFrom the posting
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.
San Francisco Bay Area Pay Range
$150,000—$175,000 USD
Equal opportunity, accessibility and legal noticesTwist Bioscience's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California25 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $150,000 | — | $175,000 |
| California (middle half) | $156,000 | $165,500 | $181,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Twist Bioscience's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Twist Bioscience's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Quality systems and risk11
- Collaboration and leadership7
- Lab testing and methods2
- Documentation and SOPs2
- Data and digital systems2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Twist Bioscience on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Associate & Specialist2 67%
- Manager1 33%
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Manager, Quality Management Systems at Twist Bioscience
Open until filled. $150K–$175K a year, employer provided.