New job SR. QUALITY ENGINEER - SAN CLEMENTE, CA - Direct hire opportunity with great medical device company! Email resumes: mhernandez@protingent.com

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Group: Job Openings, Job Leads and Job Connections! Subject: SR. QUALITY ENGINEER - SAN CLEMENTE, CA - Direct hire opportunity with great medical device company! Email resumes: mhernandez@protingent.com Monica Hernandez posted a job: SR. QUALITY ENGINEER - SAN CLEMENTE, CA - Direct hire opportunity with great medical device company! Email resumes: mhernandez@protingent.com "Our medical device client in South Orange County is looking for a Sr. Quality Engineer to join their team on a direct hire basis. Responsibilities: Implements internal quality system improvements, audits and training Supports quality control activities (including but not limited to, FMEA, hazard analysis, IQ/PQ/OQ, etc.) Supports and initiates standards and methods for inspection, testing, and evaluation of production and product quality conformance Develops and inititates sampling procedures and statistical process control methods Develops and initiates methods and instructions for recording, evaluating and reporting quality data Plans, coordinates, and executes activities concerned with development, application and maintenance of quality processes and standards for manufacturing processes, materials, and products Creates periodic quality reports supporting quality, operations, and engineering functions Interfaces with Operations for nonconforming material disposition Collaborates with Operations personnel in writing and reviewing process validation protocols and reports Compiles and writes training material and conducts training sessions on quality control activities Works with product requirements compliance as it relates to manufacturing Expresses data collected in a statistical language; reads and translates statistical data Perform other duties and responsibilities, as assigned Required Qualifications: BS in Engineering or related field and 5 to 7 years of quality assurance experience OR MS in Engineering or related field and 3 to 5 years of quality assurance experience Previous quality engineering experience in medical device industry is preferred Sound knowledge of statistical techniques and software programs (SPSS, Minitab, JMP) Six Sigma experience is preferred Sound knowledge of Microsoft Word, Excel, and Outlook Understanding of manufacturing processes, challenges, and solutions Experience with conventional inspection and measurement equipment Desired Skills/Knowledge: Knowledge of ISO standards for Class III medical devices preferred (13485, 14971) Quality auditor training preferred. Strong written and verbal communication skills. Good team work skills with internal and external customers and suppliers."

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