Dear All, If you have anyone with you for the following position, please send the suitable resume along with Contact Details, Kindly share suitable resumes ASAP to r...@sysmind.com or rjsysm...@gmail.com
*Role: Medical Devices Test Validation Engineer Location: Mounds View, MN Client: Wipro **Job Description:* Prior medical device manufacturing background and experience required. Experience in Test Method Validation and execution, Experience in TMV /Gage R& R and incoming inspections and related procedures. Experience in Receiving Inspection. Use of statistical Tools for Analysis such as Minitab etc.. Process validation working knowledge, writing the test cases of IQ/OQ/PQ protocols and execute the same in production environment. Ability to review all the protocols of IQ/OQ/PQ and provide suggestions/solutions. Manage the execution of validation protocols and write summary reports, etc., in assurance of timely and cost efficient completion through specialized experience and training as necessary. Ability to review Specifications /documents /Drawings , Details Data collection Reliability Test plan /protocols creation/ Execution Hazard Analysis / Component Design FMEA / review /verification / Updation Track the results with CAPA Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills. Process validation and working in a clean room environment and use of inspection, easuring and testing equipment. Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary. Communicate significant issues or developments identified during production, validation and qualification activities. Evaluate validation results of validation protocol executions employing specialized experience and training. Ensure validation efforts are conducted in an appropriate and timely manner. Ability to make independent decisions and successful track record of influencing key stakeholders. Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team. Knowledge on ISO 13485/Part 820 / ISO 14971 will be preferred. Skills: Demonstrate proactive and strategic thinking. Strong oral and written skills. Demonstrated problem-solving and troubleshooting skills. Demonstrated ability to exhibit a positive, energetic approach to teamwork. Demonstrate results orientation, ability to multi-task, and ability to learn quickly. Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines. Computer proficiency and high level of computer literacy. Strong interpersonal and communications skills - confident and capable in a customer facing role.Education Requirements: Bachelor s degree plus 4-6 years of related work experience would be ideal *Raj Kumar* | SYSMIND, LLC [image: https://newoldstamp.com/editor/profilePictures/profile-b15c8fc3ea4630e2ca604f11e3e951c7-41898.png] Phone: 609-897-9670 x 4002 Email: r...@sysmind.com Website: sysmind.com Address: 38 Washington Road, Princeton Junction, NJ 08550 -- You received this message because you are subscribed to the Google Groups "Open Source Erp & Crm" group. To unsubscribe from this group and stop receiving emails from it, send an email to open-source-erp-crm+unsubscr...@googlegroups.com. To post to this group, send email to open-source-erp-crm@googlegroups.com. Visit this group at http://groups.google.com/group/open-source-erp-crm. For more options, visit https://groups.google.com/d/optout.
