VP, Quality Assurance - Medical Device - Orange County, CA

This position is open as of 5/9/2008. Are you a fit? Click Here to Apply Now! Job Details VP, Quality Assurance - Medical Device - Orange County, CA renderImage('http://www.cybercoders.com/images/search.png', 84, 39); Specifications Location   Irvine, CA; Los Angeles, CA Salary   $150,000 - $175,000 Education   Bachelor of Science Category   Pharmaceutical Experience Required   At least 2 Years Short Description   VP, Quality Assurance - Medical Device - Orange County, CA Required Skills   Quality Assurance, Medical Device, Manufacturing, GMP Compliance, ISO 13485, Regulatory Recruiter   David Wright Date Updated   5/9/2008 Job Description Skills Required Quality Assurance, Medical Device, Manufacturing, GMP Compliance, ISO 13485, Regulatory Job Description VP, Quality Assurance - Medical Device - Orange County, CAWe design, develop and market drug delivery systems that are redefining the standard of care by providing life enhancing, cost effective solutions for pain relief. Responsibilities:* Accountability for Quality Assurance department and all QA functions. * QA input to Company strategic goals in form of schedules, quality plans, and budgets. * Develop, implement and maintain effective systems and procedures for ensuring product quality. * Interface with Product Development, Manufacturing, Regulatory Affairs and Logistics on problem solving and continuous improvement. * Oversee the management of quality engineering activities such as FMEAs, product and process validations, quality planning, failure analysis, test plans and qualification testing, supplier quality selection and auditing, internal auditing, SPC, inspection planning and implementation such as first article, receiving inspection, in-process and final inspections, and sterilization qualification and validation. * Oversee the development, implementation and maintenance of Quality Assurance systems and activities in accordance with applicable regulatory standards and Company objectives. * Partnership with manufacturing to drive lean manufacturing concepts and product cost improvement. * Ensure GMP compliance. * Oversee ISO Certification. * Define company quality training needs. Oversee implementation and maintenance of a training system to meet defined needs.Requirements:* 10+ years Quality Assurance and/or engineering in manufacturing positions in the medical device industry. * Background of FDA, QSR, ISO 9001 and ISO 13485 required. * TQM, Lean Manufacturing, and Six Sigma working knowledge required. * Experience in high volume manufacture of medical devices. * Possess strong interpersonal skills and leadership ability. * B.S. in Engineering, Technology, QA or equivalent industry. Must be authorized to work in the United States on a full-time basis for any employer. Location: Irvine, California; Los Angeles, California Want to interview today? Click Here to Do a Quick 2-Minute Online Interview! Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: Email your resume in Word to: David.Wright@CyberScientific.com **Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp : DW-CA-VPQA -- in the email subject line for your application to be considered.*** David Wright - Senior Recruiter - CyberScientific   logET();PauseFooter(false);