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Quality Assurance Engineer

Quality Assurance

Santa Barbara, CA

 

Sientra is searching for a Quality Assurance Engineer to join our growing Quality Assurance team!

 

The Quality Assurance Engineer (QAE) is responsible for the implementation and maintenance of quality management systems related to design control, data analysis and risk management systems and programs, analyzing, identifying and implementing manufacturing and business process improvements to enhance the capability and performance of Sientra quality systems and the manufacturing and quality systems of contract manufacturers. The QAE is responsible for the analysis of quality and (primarily) contract manufacturing systems, trouble-shooting problems and providing input to ensure timely and effective corrections and corrective and preventive action as required. The QAE will analyze quality and manufacturing systems and processes in order to identify and mitigate possible sources of increased risk to product and processes; users and patients. The QAE will apply risk management techniques (FMEA, Fish-Bone, Histograms) and principles and provide follow-up in order to minimize, monitor and control the probability and impact of identified risks and events. The QAE will participate in design control and design change projects, maintaining design control and design history files and risk management files, and is responsible for ongoing integration of information inputs into those files and systems. The QAE will understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs, as well as applicable federal, state and local regulations.

 

 

Additional Duties and Responsibilities

 

Qualifications

Education & Experience

If you would like to apply for this position, please email your resume to careers@sientra.com.