Staff Quality Engineer: Build & Lead IVD Quality System

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

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