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Quality Engineer- 64365042LB

Job Code: 64365042
Job Location: Valencia, CA
Category: Quality Engineer
Last Updated: 09/10/2019
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Quality Engineer
• Develop & implement quality system elements related to failure analysis of returned medical devices with mechanical components.
• Create testing, failure analysis and other SOP/WIs required for investigating root cause of failed products returned by customers.
• Create the complaint coding structure and trending requirements for complaint and failure types.
• Create/document test types and validate the test methods needed for product failure analysis process.
• Create list of the equipment needed for the failure analysis, conduct validation of test methods and assess need for calibration.
• Validate methodology for decontamination of explanted components.
• Help understand the intake process for complaints and create related documents as needed.
• BSME with min of 4 years’ experience in mechanical design and failure analysis OR MSME with min of 2 years’ experience in mechanical design and failure analysis
• Experience in creating SOP/WI
• Knowledge of medical device regulation related to complaints and product return investigation is a plus
• Must share time between Carlsbad and Valencia sites in California
Equal Opportunity Employer
For more information about this position, please contact the Entegee New Hope, MN office at
763-577-9000 or
Please reference job # 64365042LB


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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