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 "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to oraapps+unsubscr...@googlegroups.com. To post to this group, send email to oraapps@googlegroups.com. Visit this group at https://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/d/optout.
