Hi,
This is *Ambica* from *Deegit Inc*, I have a good position for you, thought if I can share the details and then confirm from you about your interest level for the opportunity. If you are interested and available send me your most updated resume in word format. *Role: Process Validation, IQ, OQ, PQ* *Location: Brooklyn Center, MN, USA* *Duration: 6+ Months contract* *JD:* 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. *Please send me your resume along with the following details:* Full Legal Name: Visa/Legal Status & Visa Expiry Date: Current Location: Willing to Relocate: Skype ID: SSN (Last 4 Digits): Education with University details (Year of passing ): Last project ended date along with reason (reasons can be): LinkedIn ID: Looking forward to hear from you soon, Best regards, Ambika Kumari | Lead Recruiter [image: cid:image006.jpg@01D1CE29.01060DD0] <https://www.facebook.com/DeegitInc> *DeegitTM Inc* | Technology Consulting 1900 E Golf Rd., Suite 925 | Schaumburg, IL 60173 *Phone* 847-440-2436 ext:377 *Email* amb...@deegit.com *Skype* Ambica.kumari2 [image: cid:image007.png@01D1CE29.01060DD0] www.deegit.com [image: cid:image008.jpg@01D1CE29.01060DD0] <https://www.linkedin.com/in/ambica-paltan-lion-3k-0971b441> The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from any computer. -- -- To unsubscribe from this group, send email to cbe-software-engineer-unsubscr...@googlegroups.com For more options, visit this group at http://groups.google.com/group/CBE-Software-Engineer?hl=en --- You received this message because you are subscribed to the Google Groups "CBE Software Engineer" group. To unsubscribe from this group and stop receiving emails from it, send an email to cbe-software-engineer+unsubscr...@googlegroups.com. For more options, visit https://groups.google.com/d/optout.
