Staff Quality Engineer — Build a Next-Gen QMS for Genomics

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

Benefits offered by this job

Medical, dental, and vision coverage

Company-paid life insurance

401(k) retirement plan

Generous paid time off

Voluntary benefits and employee perks

Job summary

Sarmal is hiring a Staff Quality Engineer to build and run our quality management system hands-on as we bring molecular assays, consumables, and instruments from concept through design transfer and commercialization. This is a full-time, individual-contributor role within Operations, reporting to company leadership, with no existing quality staff.

You will own design control and DHF across concurrent programs, lead ISO 14971 risk management, implement an eQMS, and drive CAPA and supplier quality

Qualifications

• 10+ years of quality experience in medical device or IVD product development and commercialization.
• Hands-on experience building or rebuilding a quality system (document control, design control, CAPA, supplier controls).
• Own a Design History File through concept to design transfer or launch.

Responsibilities

• Design control & DHF ownership across multiple programs, from concept to design transfer.
• Lead ISO 14971 risk management and FMEA activities with data-driven decisions.
• Implement and administer the eQMS and ensure robust document control and quality records.
• Own CAPA, nonconformance, deviation management from investigation to closure.

Skills

FDA QMSR (21 CFR 820)

ISO 13485:2016

ISO 9001:2015

ISO 14971

cGMP

Education

ASQ Certified Quality Engineer (CQE)

Job description

Sarmal is hiring a Staff Quality Engineer to build and run our quality management system hands-on as we bring molecular assays, consumables, and instruments from concept through design transfer and commercialization. This is a full-time, individual-contributor role within Operations, reporting to company leadership, with no existing quality staff.

You will own design control and DHF across concurrent programs, lead ISO 14971 risk management, implement an eQMS, and drive CAPA and supplier quality