Staff Quality Engineer

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.

About the role

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.

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.

Requirements

• 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.

Qualifications

• 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

• 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

Pay

The anticipated salary range for this position is $125,000 – $160,000, depending on experience and qualifications.

Why join us

• 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