Staff Design Quality Engineer

BioTalent; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

BioTalent in San Diego seeks a hands-on Staff Quality Engineer to build a quality system from the ground up as assay, consumable and instrument programs move from concept through design transfer and commercialization. You will write procedures, train the team, audit against them and refine what doesn’t work.

This builder role requires deep regulatory exposure, ownership of DHF, and leadership across design controls, risk management and supplier quality to enable IVDR readiness and compliant

Qualifications

• 8-10+ years of quality experience in IVD product development and commercialization.
• Experience building or rebuilding a quality system from the ground up.
• Ownership of a Design History File from concept to launch.
• Command of 21 CFR 820, ISO 13485, ISO 14971 and cGMP.
• Strong applied statistics: sampling, capability, gage R&R, DOE.
• ASQ CQE certification or equivalent.
• Technical depth in molecular, assay chemistry or instrumentation.
• Bonus: IEC 62304 and premarket cybersecurity experience.

Responsibilities

• Own Design History Files and design control across programs.
• Lead ISO 14971 risk management, including FMEAs and risk verification.
• Select, implement and administer the electronic QMS.
• Run CAPA, nonconformance and deviation management end to end.
• Qualify and monitor suppliers, CDMOs and OEM partners.
• Lead process validation (IQ/OQ/PQ) and support assay/instrument/software validation.
• Build internal audit program and drive ISO 13485 and IVDR readiness.

Skills

Quality leadership

IVD knowledge

QMS implementation

Regulatory knowledge

Statistical methods

ASQ CQE

Tools

QMS Software

Job description

We're hiring a hands-on Staff Quality Engineer to build a quality system from the ground up as assay, consumable and instrument programs move from concept through design transfer and commercialization. This is a true builder role. There's no existing quality team, so you'll write the procedures, train the team on them, audit against them, and refine what doesn't work.

What you'll do

• 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

What you'll bring

• 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