{"id":4081253,"url":"https://alion.io/job/element-biosciences-director-quality","title":"Director, Quality","company":{"id":673399,"name":"Element Biosciences","domain":"elementbiosciences.com","url":"https://alion.io/company/elementbiosciences","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":3,"ghost_share":0,"stale_share":0.667,"repost_share":0.333,"time_to_fill_p50_days":46,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":152000,"max":215000,"currency":"USD","period":"year","gross":null,"usd_annual":215000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Next-Generation Sequencing","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-11T17:14:26Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-11T17:22:48Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"At Element Biosciences, we are passionate about our mission to develop high performing products to study genomics with unprecedented flexibility and quality that enable researchers to better understand biology for the improvement of global health. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.\nWe are seeking an experienced Director of Quality to lead Element Biosciences' Quality function and ensure the continued effectiveness, scalability, and maturity of our Quality Management System (QMS) as the company expands its research-use and regulated product portfolio.\nReporting directly to the Chief Supply Chain Officer, the Director of Quality will serve as Element's senior Quality leader, independent Quality authority, and Management Representative for the company's ISO 13485 Quality Management System. This role will have responsibility for Quality Systems, Quality Engineering, Supplier Quality, Quality Control and incoming inspection, Document Control, audit and inspection readiness, and product and process quality.\nThe Director will build upon Element's existing quality system foundation and partner closely with Product Development, Manufacturing, Supply Chain, Service, Regulatory Affairs, Clinical, and other functions to ensure that products and processes meet applicable quality requirements throughout the product lifecycle. The Director will promote a culture in which quality requirements are incorporated early, risks are identified and addressed proactively, and quality systems enable both compliance and efficient execution.\nIf you possess the following and want to make a meaningful impact, we invite you to explore this role.\nEssential Functions and Responsibilities:\nLead Element's Quality function and QMS, establishing Quality strategy, policies, objectives, metrics, and priorities and ensuring continued compliance with applicable quality system regulations, standards, company policies, and procedures\nServe as Management Representative for the ISO 13485 QMS, ensuring required QMS processes are established and maintained, reporting QMS performance and improvement needs to executive management, and promoting awareness of applicable quality and regulatory requirements throughout the organization\nServe as the company's senior Quality authority, providing independent judgment and escalation on significant product, process, supplier, and quality system risks and leading Management Review, CAPA, nonconformance, complaint, change control, document control, and continuous improvement processes\nLead product and process quality throughout the lifecycle, including design controls, risk management, verification and validation, new product development, design transfer, manufacturing readiness, sustaining changes, incoming/in-process/final quality controls, and product release\nOwn Supplier Quality, including supplier qualification and monitoring, risk classification, quality agreements, supplier audits, corrective actions, and escalation of significant supplier related risks\nLead organizational inspection and audit readiness, including FDA inspections, ISO certification and surveillance audits, notified body QMS audits, customer audits, and other Quality-related assessments, and ensure timely and effective resolution of findings\nPartner with Regulatory Affairs on regulated product lifecycle and post-market activities, with Quality responsible for investigation, root cause analysis, quality risk assessment, containment, and corrective action, and Regulatory Affairs responsible for regulatory impact assessments, reporting, notifications, and market authorization implications\nBuild and develop a high performing Quality organization, establishing clear accountability, decision rights, scalable processes, and a culture of proactive risk management, constructive challenge, continuous improvement, and cross-functional partnership\nEducation and Experience:\nBachelor's degree in engineering, life sciences, chemistry, or a related technical discipline; advanced degree preferred\nTypically 15+ years of progressively responsible Quality experience within medical devices, IVDs, life science tools, or similarly regulated products, including significant leadership responsibility\nDemonstrated experience leading and scaling Quality organizations and ISO 13485 Quality Management Systems, including experience serving as or working closely with a Management Representative\nDeep working knowledge of ISO 13485, FDA quality system requirements, ISO 14971, design controls, CAPA, complaint handling, change control, supplier quality, validation, and auditing principles\nDemonstrated experience leading regulatory inspections, ISO/notified body audits, and other external Quality audits, including management of findings and corrective actions\nStrong experience supporting product development, design transfer, manufacturing, and commercial product lifecycle processes; experience with complex instrumentation, IVD, NGS, software enabled products, or SaMD preferred\nStrong risk-based judgment, executive communication skills, and demonstrated ability to influence technical and business leaders while maintaining appropriate Quality independence and authority\nSelf-directed, pragmatic, collaborative, and comfortable operating in a fast-paced environment with evolving priorities; demonstrated commitment to developing people and organizational capability\nASQ certifications such as CQE, CQA, or CMQ/OE are preferred\nPhysical Requirements: \nMust be able to lift up to 15 pounds.\nLocation:\nSan Diego (on-site)\nTravel: \nWillingness to travel up to approximately 10% of the time \nJob Type:\nFull-time, Exempt\nBase Compensation Pay Range: \n$152,000 - $215,000\nIn addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off. \nPlease note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. \nWe foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.","description_format":"text","description_chars":6545,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Health insurance","Stock options"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-11-11T17:22:48Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 6","filings_12m":6,"filings_prev_12m":3,"green_card_filings_12m":0,"median_offered_wage_usd":117500,"route":null,"cap_exempt":false,"checked_at":"2026-11-11T07:38:50+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":46,"reasons":["conf:1","win:early"],"computed_at":"2026-11-11T19:08:24Z"},"pay":{"stated_usd_annual":215000,"is_top_pay":true},"html_url":"https://alion.io/job/element-biosciences-director-quality","json_url":"https://alion.io/job/element-biosciences-director-quality.json","meta":{"generated_at":"2026-11-11T19:08:24Z","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":36904,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":673399},"rest":"https://alion.io/mcp/rest/get_company?id=673399"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felement-biosciences-director-quality"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Felement-biosciences-director-quality"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Felement-biosciences-director-quality"},{"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/element-biosciences-director-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felement-biosciences-director-quality"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4081253}},{"tool":"search_jobs","arguments":{"company":"elementbiosciences.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4081253},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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