Please share resumes to anu...@reqroute.com
Role: Validation Test Engineer with medical device Location: Brooklyn Park, MN Duration: 6+ month contract *Skill and Experience Details:* Mandatory Skills: Medical Devices Testing Product Testing, Test Automation, Product verification *Job Description:* Validation Test Engineer with Medical devices experience Key skills required for the job are: · 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, measuring 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. -- 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.
