Sr QA Engineer

Sr. QA Engineer

Direct Hire. Medical Device.

Santa Ana CA. 100140k 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 ISOCFR 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.

Benefits