--- title: 'Staff Quality Engineer at Sarmal Inc' canonical: 'https://feeny.ai/job/staff-quality-engineer-sarmal-inc-san-diego-vxrwqd0gd8f6' type: 'job' last_seen: '2026-09-08' --- # Staff Quality Engineer at Sarmal Inc - **Company:** Sarmal Inc - **Location:** San Diego, CA - **Compensation:** $125k–$160k - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-08-11 - **Last confirmed live:** 2026-09-08 - **Apply:** https://jobs.lever.co/sarmal-inc/b5b845c8-b0b8-4fac-89b0-4ba568d817f9 ## Job description Company Overview Sarmal, Inc. is a San Diego–based biotechnology company developing next-generation genomics and molecular detection platforms. Our work integrates molecular biology, chemistry, and advanced systems engineering to enable faster, more precise, and more accessible genomic insights. We are a highly collaborative, R&D-driven team operating in a fast-paced, early-stage environment. Our scientists and engineers work across disciplines to solve complex technical challenges and translate innovation into scalable, real-world applications. At Sarmal, we value scientific rigor, curiosity, and a builder mindset. We are looking for individuals who are energized by ambiguity, motivated by impact, and excited to help bring breakthrough technologies from concept to reality. ## About the Job Sarmal is hiring a Staff Quality Engineer to build and run our quality management system hands-on as we bring molecular assay, consumables, and instrument programs from concept through design transfer and commercialization. This is a full-time, individual-contributor role within Operations, reporting directly into company leadership, with no existing quality staff or precedent to lean on — you will write the procedures, train the team on them, audit against them, and revise what doesn't work. You will own design control and Design History Files across multiple concurrent programs, lead ISO 14971 risk management, implement and administer our eQMS, run CAPA and nonconformance to closure, qualify suppliers and CDMO partners, and drive process and software validation — right-sizing every control to a 30–50 person organization without leaving audit exposure. ## Key Responsibilities - Design control & DHF ownership — own Design History Files across multiple molecular assay, consumables, and instrument programs from concept through design transfer. - Risk management — own ISO 14971 risk management files, hazard analysis, dFMEA/pFMEA/uFMEA, risk control verification, and benefit-risk rationale, feeding directly into design and process decisions. - eQMS implementation & administration — select, implement, and administer the electronic quality management system as the backbone of document control and quality records. - CAPA, nonconformance & deviation management — own the full loop: investigation, root cause, corrective/preventive action, effectiveness checks, and trending into management review. - Supplier quality & purchasing controls — qualify and monitor critical suppliers, CDMO partners, and OEM chemistry sources; own incoming inspection criteria and supplier corrective actions. - Validation — lead process validation (IQ/OQ/PQ) with defensible statistical rationale; support assay, consumables, instrument, and software validation, including computer system validation under an SDLC framework. - Audit & certification readiness — run the internal audit program; prepare for and support notified body, supplier, and regulatory audits; drive the system toward ISO 13485 certification and IVDR technical documentation readiness. ## Qualifications - Working command of FDA QMSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, ISO 14971, and cGMP. - ASQ Certified Quality Engineer (CQE) or equivalent certification. - Sound applied statistics for quality engineering: sampling plans, process capability, gage R&R, and method validation — able to defend the rationale, not just execute the protocol. - Familiarity with IEC 62304 and premarket cybersecurity documentation preferred. - Sufficient technical depth across molecular/genomics, assay chemistry, or instrumentation to review technical data and credibly challenge conclusions. Education & Experience - 10+ years of quality experience in medical device or IVD product development and commercialization, with demonstrated progression across multiple quality functions. - Hands-on experience building or substantially rebuilding a quality system — document control, design control, CAPA, supplier controls — rather than solely operating within an established one. - Demonstrated ownership of a Design History File through at least one product from concept to design transfer or launch. - Process validation experience (IQ/OQ/PQ) with sound applied statistics, including DOE familiarity. - A builder's mindset: comfortable operating without support staff or precedent, with the pragmatic judgment to right-size controls and the credible independence to hold the line with engineering, R&D, and executive stakeholders on the things that matter most. ## Benefits & Perks Sarmal offers a competitive and comprehensive benefits package, including: - Medical, dental, and vision coverage - Company-paid life insurance - 401(k) retirement plan - Generous paid time off - Access to additional voluntary benefits, employee perks, and discount programs - We are committed to supporting the well-being of our employees and providing a strong foundation for both professional and personal success. ## Why Join Sarmal Work on cutting-edge genomics and molecular detection technologies Collaborate with a deeply technical, cross-functional team Contribute to foundational platform development at an early stage Have visibility into and impact on core technical and strategic decisions Help shape the infrastructure, culture, and future direction of the company Closing Statement Join us in advancing the next generation of genomic technologies and shaping the future of precision health. ## About Sarmal Inc ## Company Overview - **One-liner**: Sarmal is a San Diego-based genomics company developing next-generation innovations in advanced nucleic acid sequencing and target sequence detection. - **Entity Type**: Private (Venture Capital-Backed; Latest Deal Type: Series A1) - **Headquarters**: San Diego, California, United States (9310 Athena Circle, Suite 250, La Jolla, CA 92037) - **Founded**: 2019 - **Founders**: Inanc Ortac (CEO, Founder, CSO) ## Core Business - **Primary Industry**: Biotechnology / Genomics - **Target Customers**: B2B (healthcare and research sectors) - **Mission/Purpose**: To develop breakthrough technologies in advanced nucleic acid sequencing and nucleic acid-based detection, making genetic analysis and molecular testing fast, accessible, and cost-effective. ## Products & Services - **FLASH Sequencing Platform**: A single-molecule DNA sequencing technology that can achieve unlimited read lengths, enabling whole-genome sequencing with low-cost devices and low error rates. - **TEEM Target Detection Platform**: A portable, field-deployable nucleic acid-based diagnostic platform for molecular testing. ## Market Standing - **Valuation**: Not publicly available (latest round: Series A1) - **Key Metric**: Total Funding of $5M (Series A1, closed January 2026) - **Notable Investors**: BUBA Ventures, MENE Ventures - **Growth Signals**: Headcount has grown 300% year-over-year to 14 employees; active job postings (2 open roles as of latest data); has filed 7 patents, with one granted in August 2024 for "Methods for single molecule sequencing." ## Competitive Advantages - **Proprietary Technology**: The FLASH Sequencing Platform’s ability to achieve unlimited read lengths is a significant differentiator in the genomics field, potentially enabling lower-cost, more comprehensive genome sequencing. - **Interdisciplinary Team**: Combines expertise across biology, chemistry, engineering, and software to build transformative genomic technologies. - **Patent Portfolio**: 7 patents filed, providing intellectual property protection for core technologies. ## Strategic Focus - **Current Priority**: Scaling the team and advancing both the FLASH Sequencing and TEEM Target Detection platforms from R&D toward commercialization. - **Direction**: To transform genomics by making whole-genome sequencing accessible and field-deployable diagnostics a reality. ## Why Work Here - **Culture**: A small, entrepreneurial R&D team (14 people) focused on breakthrough innovation. The team brings together interdisciplinary expertise, offering a hands-on, high-impact environment. - **Work Policy**: All current job postings (Associate Director - Microbiology, Test Engineer 2, Procurement Specialist, Research Associate II, Scientist/Sr. Scientist, Staff Sci, RA II/Sr. RA) are listed as **On-site** in San Diego. No remote or hybrid options are currently advertised. - **Notable Perks**: The company uses AI tools to support the hiring process but emphasizes that final hiring decisions are made by humans. The small team size suggests significant ownership and visibility across projects. - **Engineering Culture**: Strong focus on cutting-edge science in a startup environment; employees come from companies like Encodia, Ansa Biotechnologies, and TriLink BioTechnologies. ## Sources 1. [LinkedIn - Sarmal Inc](https://linkedin.com/company/sarmal-inc) 2. [Sarmal Careers Page (Lever)](https://jobs.lever.co/sarmal-inc) 3. [CB Insights - Sarmal](https://www.cbinsights.com/company/sarmal) 4. [PitchBook - Sarmal Company Profile](https://pitchbook.com/profiles/company/593263-63) 5. [The Org - Sarmal, Inc.](https://theorg.com/org/sarmal-inc) ## Other roles at Sarmal Inc - [Procurement Specialist](https://feeny.ai/job/procurement-specialist-sarmal-inc-san-diego-2mqhwvadr5vz) — San Diego, CA - [Sr Manufacturing Technician](https://feeny.ai/job/sr-manufacturing-technician-sarmal-inc-san-diego-g72v8n3ftbpg) — San Diego, CA - [RA II or Sr. RA -Systems Integration](https://feeny.ai/job/ra-ii-or-sr-ra-systems-integration-sarmal-inc-san-diego-mf4tdsgppr89) — San Diego, CA - [Product Manager](https://feeny.ai/job/product-manager-sarmal-inc-san-diego-1k3wv4s7cv43) — San Diego, CA - [Sr. Research Associate -Systems Integration](https://feeny.ai/job/sr-research-associate-systems-integration-sarmal-inc-san-diego-zy5jkraf83cm) — San Diego, CA - [Principal Mechanical Engineer](https://feeny.ai/job/principal-mechanical-engineer-sarmal-inc-san-diego-rc7g03tfamk1) — San Diego, CA - [Scientist/Sr. Scientist, Biochemistry – NGS Assay Development](https://feeny.ai/job/scientist-sr-scientist-biochemistry-ngs-assay-development-sarmal-inc-san-diego-pys1d4fzxwcy) — San Diego, CA - [Staff Sci, Assay Development (Reagents)](https://feeny.ai/job/staff-sci-assay-development-reagents-sarmal-inc-san-diego-1t8tdt6e2rdn) — San Diego, CA - [Principal Optical Engineer](https://feeny.ai/job/principal-optical-engineer-sarmal-inc-san-diego-ecxpfer56wha) — San Diego, CA - [Sr./Staff Scientist – Surface Chemistry](https://feeny.ai/job/sr-staff-scientist-surface-chemistry-sarmal-inc-san-diego-ndz1ttvh2jdv) — San Diego, CA