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Sr. QA Engineer
Direct Hire. Medical Device.
Santa Ana, CA. 100-140k DOE
Talentry is looking for an Sr. Quality Assurance Engineerfor our diagnostics device design and manufacturing client. The right QE isgoing to enrure that all applicable regulations are followed. This includes,but is not limited to, ISO13485, 21 CFR part 820, ISO14971 etc. Thie engineerwill support engineering, manufacturing, R&D and Operations to improveproduct design, quality, and reliability.
This Quality professional will review requirements, developrisk analysis profiles, design verification and validation reports andprotocols, develop and manage testing protocols and documentation, maintain DHFs,conduct NCR/CAPA investigations, and participate in audits.
BS in science, engineering, quality, or similar, and 6 years of experience.
Demonstrated medical device quality assurance experience.
Proven ISO 13485 / FDA 21 CFR820/ ISO 14971 experience.
Proven champion of quality.
Strong documentation, risk analysis, v&v, and investigativeexperience.
Proven experience with QMS software.
Excellent communication and documentation skills are a must.
Full Time
$93k-109k (estimate)
01/25/2024
05/24/2024
talentry.net
San Diego, CA
<25
The following is the career advancement route for Sr. QA Engineer positions, which can be used as a reference in future career path planning. As a Sr. QA Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr. QA Engineer. You can explore the career advancement for a Sr. QA Engineer below and select your interested title to get hiring information.