Job Description:Global leader in the healthcare/medical product manufacturing industry is currently looking for an Engineer II in Hayward CA.. This is a contract opening expected to last 12 months, could be longer based on performance, possible temp to hire. This position will provide quality support throughout lifecycle for new product development projects, engineering changes, design control activities, updating risk management files, reviewing and approving DMRs. New grads are encouraged to apply! Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now! Responsibilities for the Product Engineer * Provide quality support and review of change control as it relates to new product development and product modifications or changes * Design control activities, reviewing / updating risk management files, reviewing and approving DMRs * Represent quality at project meetings and provide quality guidance to project management as it relates to new product * Support annual quality report for medical device products * Write, revise, and review SOPs * Ensure quality and consistency in documentation and adherence to SOPs * Maintain expertise in quality systems (e.g. change control, critical system, etc) and ability to initiate and execute change control requests * Work closely with the R&D and technical group to provide on-going Quality support Requirements for the Product Engineer * BS in Engineering (Mechanical, Chemical, Bioengineering, or Biomedical), MS preferred * 2+ years medical device or pharma product development experience providing quality support (requirements development, engineering changes, validation, design control, or verification) * Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) * Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations < Benefits for the Product Engineer * Paid Vacation * 401K * Health Insurance, and more... Related Words: medical device, quality, product development, biomedical, pharma, mechanical engineer, mechanical engineering, bsme, capa, complaint investigation, 21 cfr part 820, quality assurance, quality, qa, qc, statistical process control, spc, total quality management, tqm, process analyst, inspection, inspection, iso, taquchi, sampling theory, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, black belt, master blackbelt, master blackbelts, engineering technician ()
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