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TECHNOI.OGIES-

Job Description: Quality Engineer

SUMMARY DESCRIPTION

Directs and participates in quality assurance efforts to ensure that the Company products conform to quality standards and that processes and controls adhere to regulatory requirements. Performs activities associated with RMA, NCMR and CAPA processes.
MINIMAL ESSENTIAL DUTIES AND RESPONSIBILITIES

 1- Works with suppliers in resolving quality issues with non-conforming raw materials and components by implementing Corrective and Preventive action.
 2- Supports the internal audit program as required.
 3- Develops and improves inspection techniques.
 4- Manages MRB process and ensures non conforming product has been dispositioned in accordance with applicable regulatory requirements.
 5- Establishes root cause and appropriate Corrective/Preventive Action to eliminate existing or potential nonconformance conditions.
 6- Provides necessary training for inspection and production personnel as may be required.
 7- Works directly with Product Engineering to address corrective actions and out-of-control events.
 8- Creates and submits Engineering Changes, Drawings, Procedures, Rework Instructions and Variance Authorizations as required.
 9- Participates and supports process development as related to supplier development/qualification, quality processes/tooling, and risk management activities such as FMEA.
 10- Develops and coordinates execution of process validation protocols and reports ensuring proper statistical analysis is applied.
 11- Develops analysis methods for determining reliability of components, equipment, and processes. Acquires data and performs analysis of data for reporting quality system metrics.
 12- Applies statistical and QE tools such as SPC, DOE, Hypothesis testing, R&R cage studies.
 13- Perform the role of Reviewer in the Complaint Management and CAPA systems.

Skills / Requirements

MINIMUM QUALIFICATIONS
1- Education: AA degree in a technical discipline or BS preferred
2- Experience: 2 years minimum medical device manufacturing in Quality Engineering.
3- Experience in root cause analysis for disposition and corrective action required
4- FMEA/SPC/Statistics/Validation experience is a plus
5- Knowledge/training of ISO 9001:2008 or ISO 13485:2003 preferred
6- Spanish speaking is a plus

120 Knowles Drive,
Los Gatos, CA 95032 
rlS 408-376-3400 
3 408-376-3414