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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: I'm hiring for this position - fantastic work environment - know anyone who might be a good fit? Matt Turner posted a job: I'm hiring for this position - fantastic work environment - know anyone who might be a good fit? "Hiring a SENIOR QUALITY ENGINEER in Los Angeles, CA SENIOR QUALITY ENGINEER Simply Biotech specializes in recruiting exclusively for the biotech and medical device community. We are currently seeking a Senior Quality Engineer for a leading and growing Orange County medical device firm.   The qualified Sr. Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products. This person will collaborate with the R&D organization to help facilitate the successful execution of the New Product Development Process and launching of robust products. Responsible and accountable for Quality Engineering deliverables required within the product development program. The Sr. QE will: * Be responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures. * Collaborate with the R&D organization to help facilitate the successful execution of the NPD process and launching of robust products. Provide expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques. * Lead test method development/validation activities for New Product Development programs. * Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives. * Facilitate Risk Management process in compliance to appropriate external standards and corporate policies. Provide technical support to NPD teams in generating risk files for new products. * Lead failure investigations for product failures encountered during the New Product Development. * Ensure Quality Engineering support of customer complaint investigations as required. * Maintain an up-to-date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques. Maintain an up-to-date knowledge of the company products, policies, and procedures.   The qualified Sr. Quality Engineer will possess: * Minimum BS Degree in Science, Engineering, or related field is required * Minimum 8-12+ years experience in the medical device industry * Working knowledge of GMP/QSR, ISO, Medical Device Directive, and other applicable regulations is expected. * Working knowledge of desktop computer, office software, and e-mail is required. * Ability to handle multiple tasks simultaneously and ability to manage project timelines. * Must be accurate in handling detailed information/data. * Excellent verbal and written communication skills. * Ability to travel within the US and internationally approximately 15%   For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507.   More information can be found at www.simplybiotech.com. http://bull.hn/l/GBLD/3"

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