{"id":2534827,"url":"https://alion.io/job/twist-bioscience-manager-quality-management-systems","title":"Manager, Quality Management Systems","company":{"id":1814479,"name":"Twist Bioscience","domain":"twistbioscience.com","url":"https://alion.io/company/twistbioscience","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":82,"open_postings":9,"ghost_share":0,"stale_share":0.667,"repost_share":0.111,"time_to_fill_p50_days":37,"computed_at":"2026-10-16T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":175000,"currency":"USD","period":"year","gross":null,"usd_annual":175000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-14T12:27:42Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-16T06:58:27Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"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.\nWhat You’ll Do\nImplement and maintain QMS procedures that comply with ISO 13485:2016 and other applicable regulations, and support certification across product lines.\nOwn the internal and external audit program. This includes setting the audit schedule, conducting audits, and identifying and resolving nonconformities.\nManage the local and global audit team.\nOwn the quality training program, including curriculum development, training assignments, and completion tracking across all disciplines.\nLead Quality Assurance initiatives and projects focused on audit, training, and compliance.\nOversee QMS compliance for all personnel and functions.\nMake sure supplier quality objectives are met.\nSupport the product and software development lifecycles with appropriate design controls.\nMaintain monitoring and measurement systems and drive continuous improvement.\nTrain and mentor QA team members on QMS principles, ISO 13485, and regulatory compliance.\nStay current on industry trends and regulatory changes in genomics.\nWhat You’ll Bring\nBachelor’s degree in Engineering, Physical/Life Sciences, or a related field (Master’s preferred).\n7+ years of experience in the medical device or biotechnology industry, with a strong focus on QMS and ISO 13485 compliance.\nProven experience developing and implementing QMS procedures and conducting internal and external audits.\nWorking knowledge of ISO 13485, genomics, and regulatory compliance.\nHands-on experience with QMS management software.\nExperience with the product development lifecycle and product commercialization, including guiding large-scale programs toward commercialization goals.\nStrong supervisory, organizational, analytical, and problem-solving skills.\nExcellent written and verbal communication, collaboration, and leadership skills.\nAbility to work independently and on a team in a fast-paced environment.\nNice to Have\nExperience in the genomics industry.\nExperience with FDA regulations for medical devices and IVDs.\nExperience with EU IVDR.\nExperience with GMP requirements.\nDeep knowledge of risk management and design controls.\nSix Sigma or other quality improvement methodology experience.\nAbout Twist Bioscience\nTwist 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.\nAt 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.\nTwist 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.\nThe 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 compensationamounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensationmay be different in other locations.\nSan Francisco Bay Area Pay Range\n$150,000—$175,000 USD","description_format":"text","description_chars":4055,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Genomics & Genetic Testing","Synthetic Biology"],"lifecycle":[{"event":"open","at":"2026-10-14T13:53:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 15 · green card filings: 5","filings_12m":15,"filings_prev_12m":20,"green_card_filings_12m":5,"median_offered_wage_usd":133750,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":37,"reasons":["conf:3","velocity","win:early"],"computed_at":"2026-10-16T05:45:00Z"},"pay":{"stated_usd_annual":175000,"is_top_pay":true},"html_url":"https://alion.io/job/twist-bioscience-manager-quality-management-systems","json_url":"https://alion.io/job/twist-bioscience-manager-quality-management-systems.json","meta":{"generated_at":"2026-10-16T08:32:25Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":6473,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1814479},"rest":"https://alion.io/mcp/rest/get_company?id=1814479"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftwist-bioscience-manager-quality-management-systems"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ftwist-bioscience-manager-quality-management-systems"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ftwist-bioscience-manager-quality-management-systems"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/twist-bioscience-manager-quality-management-systems\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftwist-bioscience-manager-quality-management-systems"}]}