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# Staff Design Quality Engineer

- **Company:** BioTalent
- **Location:** Poway, CA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Verification and Validation (Software), Iq/oq/pq, Model Validation
- **Published:** October 9, 2026
- **Apply:** https://www.disabledperson.com/jobs/75921625-staff-design-quality-engineer

## About the Role

* 8-10+ years of quality experience within IVD product development and commercialization
 * Experience building or substantially rebuilding a quality system, not just operating within one
 * Ownership of a Design History File for at least one product from concept to design transfer or launch
 * Working command of 21 CFR 820 (QMSR), ISO 13485, ISO 14971 and cGMP
 * Strong applied statistics: sampling plans, process capability, gage R&R, method validation and DOE
 * ASQ CQE certification or equivalent
 * Enough technical depth in molecular, assay chemistry or instrumentation to credibly challenge data
 * Bonus: IEC 62304 and premarket cybersecurity experience

## Description

* Own Design History Files and design control across multiple assay, consumable and instrument programs
 * Lead ISO 14971 risk management, including hazard analysis, design/process/use FMEAs, and risk control verification
 * Select, implement and administer the company's electronic QMS
 * Run CAPA, nonconformance and deviation management end to end, from root cause to effectiveness checks
 * Qualify and monitor suppliers, CDMOs and OEM partners, including incoming inspection and supplier corrective actions
 * Lead process validation (IQ/OQ/PQ) and support assay, instrument and software validation
 * Build the internal audit program and drive toward ISO 13485 certification and IVDR readiness