Staff Quality Engineer – Build QMS for Genomics

Sarmal Inc; San Diego (CA); On-site; USD 125,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision

Company-paid life insurance

401(k) retirement plan

Generous paid time off

Voluntary benefits and well-being

Job summary

Sarmal, Inc is seeking a Staff Quality Engineer in San Diego to own and advance our quality management system across molecular assay, consumables, and instrument programs. This individual will write procedures, train staff, audit against them, and drive design control and risk management in a resource-constrained, early-stage environment.

You will lead CAPA, supplier qualification, and multiple validation efforts while collaborating with R&D and Operations leadership to ensure compliance and

Qualifications

• 10+ years of quality experience in medical device or IVD product development and commercialization.
• Hands-on experience building or substantially rebuilding a quality system (document control, design control, CAPA, supplier controls).
• 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.
• Builder’s mindset: comfortable operating without support staff or precedent, with pragmatic judgment to right-size controls.

Responsibilities

• Own design control and DHF across multiple programs from concept through design transfer or launch.
• Lead ISO 14971 risk management, hazard analysis, and risk control verification; inform design and process decisions.
• Implement and administer the electronic quality management system (eQMS) as the backbone of document control.
• Manage CAPA, nonconformance, and deviations from investigation through closure and trend analysis.
• Qualify and monitor critical suppliers and CDMO partners; establish supplier inbound inspection criteria.
• Lead IQ/OQ/PQ process validation with defensible statistical rationale and support for various validation activities.
• Support internal audits and readiness for notified body, supplier, and regulatory audits; push toward ISO 13485 and IVDR readiness.

Skills

Quality engineering

Statistics

Audit readiness

Education

ASQ CQE certification

Job description

Sarmal, Inc is seeking a Staff Quality Engineer in San Diego to own and advance our quality management system across molecular assay, consumables, and instrument programs. This individual will write procedures, train staff, audit against them, and drive design control and risk management in a resource-constrained, early-stage environment.

You will lead CAPA, supplier qualification, and multiple validation efforts while collaborating with R&D and Operations leadership to ensure compliance and