*Job Title* Product Quality Engineer
*Relevant Experience* *(in Yrs)* 6 Year in Medical Industry or regulated industry *Technical/Functional Skills* *Roles & Responsibilities* - Quality Engineering working knowledge and Quality Management Experience - working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines - Strong working knowledge of ISO 14971 Risk Management Process (System Risk Analysis, DFMEA/FMEA and other Risk Management tools) - Extensive design/sustaining quality experience within medical device industry. - New product development and post launch support activities, Product remediation and risk management activities - Working knowledge of Microsoft office products (MS Word, Excel) and Statistical Analysis Software tools - Writing protocol and reports for design and product validation, and execution - Engineering change order - Development of a Standard Procedure (SP), related Work Instructions (WI), Forms, Checklists for design verification and validation activities - Ensure robust technology transfer to products from the development stage to post launch/operations - Support the development of product, process and packaging requirements in that are complete, compliant and effective - Ensure product, systems and processes are current in relation to global regulatory requirements - Work with Core Teams and development partners to ensure robust design quality practices are embedded and applied - Work with Quality Engineers and project teams to ensure the continued application of Risk Management principles in the post-launch environment - Partner with Reliability Engineering to ensure that robust design reliability practices are embedded and applied - Define the controls and quality standards for new products and design changes - Identify opportunities to continuously improve quality, cost and time factors, consistent with business objectives - Provide constructive technical challenge to R&D and other technical functions to drive better team performance and project outcomes - Support organizational development and improvement of the quality system *Duration of assignment *(in Months) 12 Months *Work Location* (State, City and Zip) Irvine, CA * Regards,* *Atul Sharma* IT -recruiter a...@idctechnologies.com <ashw...@idctechnologies.com> Direct: 408.418.5778 <(408)%20418-5778> EXT 3027 -- You received this message because you are subscribed to the Google Groups "only.SAP" group. To unsubscribe from this group and stop receiving emails from it, send an email to onlysap+unsubscr...@googlegroups.com. To post to this group, send email to onlysap@googlegroups.com. Visit this group at https://groups.google.com/group/onlysap. For more options, visit https://groups.google.com/d/optout.
