Hi Folks, Please share the suitable resource for this Position. Please share the Visa Copy and Photo ID Proof of your consultants. at *manish.gu...@nityo.com <manish.gu...@nityo.com>* =================================================================
*Role : Product Quality Engineer * *Work Location : Irvine, CA* *Duration of assignment (in Months) : 12 months* *Relevant Experience: 5-6 Year in Medical Industry or regulated industry* *Technical /Functional Skills* • 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 *Roles & Responsibilities* • 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 Thanks & Regards! *Manish Gupta* *Desk : **609-853-0818 **Ext. 2130* *Email : manish.gu...@nityo.com <manish.gu...@nityo.com>* -- You received this message because you are subscribed to the Google Groups "International SAP Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to international-sap-projects+unsubscr...@googlegroups.com. To post to this group, send email to international-sap-projects@googlegroups.com. Visit this group at https://groups.google.com/group/international-sap-projects. For more options, visit https://groups.google.com/d/optout.
