Dear Associates,
This is *Nishanth *from* **EZEN Computer Services Inc.* Please do let me know if you have anyone for the below requirement. Kindly reply me with updated resume in word format, contact information, current location, visa status and rate. *Position:** Quality Engineer in Medical Devices* ***Location:** Irvine, CA* *Duration:** 6 months+*** * * *JOB Description* *SUMMARY:* The Quality Engineer (Failure Analysis) is responsible for failure analysis of complaints and other complaints related activities. *ESSENTIAL DUTIES AND RESPONSIBILITIES* · In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering projects or a number of small projects with varying levels of complexity. · In a supervisory capacity, plans, develops, coordinates, mentors, and directs technicians and junior level engineers. · Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. · Performs complaint analysis. · Reviews and approves failure analysis reports · Might assist Regulatory Affairs in developing submissions for new devices as necessary. · May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers. · Develop and establish effective quality control and associated risk management plans. · Makes decisions independently on engineering problems and methods, and represents the organization in conferences to resolve important questions and to plan and coordinate work. Consults with supervisor concerning unusual problems and developments. · As needed, write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders. · Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). · Direct and perform risk assessments such as Failure Mode and · Effects Analysis and Health Hazard Evaluations · As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures. · Work is expected to result in the development of new or improved techniques or procedures. · Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods. · Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable. · If needed, might be responsible for submitting MDRs to FDA · Responsible for managing process related to failure analysis of hardware and disposable product complaints. · Analyzes reports and recommends corrective action. · Responsible for complaints trending reports, statistical analysis, presentation of data, and providing recommendations. *QUALIFICATION REQUIREMENTS* · EDUCATION and/or EXPERIENCE: BS in engineering, physical, biological, or natural sciences required, along with a minimum of 5 years of quality, manufacturing, or research and development experience in medical devices preferably in vascular product line. · Experience in a medical device or other regulated industry is desired, but not required. · American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools are desirable. *OTHER SKILLS and ABILITIES:* · Must possess the basic understanding of engineering fundamentals. · Good written and oral English communication skills. Must be computer literate. *Thanks & Regards,** Nishanth.* *EZEN Computer Services, Inc || "Leading by Innovative Thoughts"||** Ph: (609)-945-2911 ||www.e-zencomp.com ||Partner to PTC Arbortext products ||* -- You received this message because you are subscribed to the Google Groups "American Vendor--IT Consulting" group. To post to this group, send email to sap-vendor@googlegroups.com. To unsubscribe from this group, send email to sap-vendor+unsubscr...@googlegroups.com. For more options, visit this group at http://groups.google.com/group/sap-vendor?hl=en.
