Sr Qa Engineer

Sr. QA Engineer

Direct Hire. Medical Device.

Santa Ana, CA. 100-140k DOE

Talentry is looking for an Sr. Quality Assurance Engineer for our diagnostics device design and manufacturing client. The right QE is going to enrure that all applicable regulations are followed. This includes, but is not limited to, ISO13485, 21 CFR part 820, ISO14971 etc. Thie engineer will support engineering, manufacturing, R&D and Operations to improve product design, quality, and reliability.

This Quality professional will review requirements, develop risk analysis profiles, design verification and validation reports and protocols, develop and manage testing protocols and documentation, maintain DHFs, conduct NCR/CAPA investigations, and participate in audits.  

Requirements

BS in science, engineering, quality, or similar, and 6+ years of experience.

Demonstrated medical device quality assurance experience.

Proven ISO 13485 / FDA  21 CFR  820 / ISO 14971 experience.

Proven champion of quality.

Strong documentation, risk analysis, v&v, and investigative experience.

Proven experience with QMS software.

Excellent communication and documentation skills are a must.