Hiring NPI Validation Engineer in Irvine, CA at Irvine, Kentucky, USA |
Email: [email protected] |
From: Naveen M, Siri Info [email protected] Reply to: [email protected] Hello Greetings from Siri InfoSolutions We have an immediate position, please find the below details Role: NPI Validation Engineer Location: Irvine, CA Duration: 6+ months Contract Essential Skills: NPI Validation Engineer 3+ years of medical device experience in NPI, Windchill PLM Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, lay-out, fabrication, modification, and assembly of mechanical or electrical equipment and/or components. Experience in validation of product and equipment. Experience in New Product Introduction (NPD) with Solidworks. Knowledge of good manufacturing practices and documentation, preferably in the medical industry. Risk management experience pFMEA and dFMEA. Knowledge on QMS - NC, CAPA and contribution in audits and ETQ instinct experience if any Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP. JnJ experience with ADAPTIV and Windchill PLM Oral and written communication in English. NPI Validation experience, preferably knowledge in the medical industry. Desirable Skills: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Identifies, designs, and develops the necessary equipment related to new product Introduction. Initiate Validation Master Plan for new projects Develop manufacturing process for new projects. Perform IQ, OQ, PQ protocol writing and validation activities. Guage R&R approach Studies the existing processes to implement improvements on new products. Perform NPI prototyping, NPI project phase. Responsible for preparing and managing specifications. Performs activities of process/product validation. Manage the projects by conducting meetings, tracking milestones, define project plan. Responsible for communicating business related issues or opportunities to next management level. Performs other duties assigned as needed. Project Management experience Bachelor of Engineering, any specialty. Thanks & Regards, Naveen Miyyadi | Team Lead | Email: [email protected] | Phone : 732-797-9367 Siri InfoSolutions Inc, 3 Ethel Rd, Suite # 302, Edison NJ 08817. CPUC Certified Disclaimer: We respect your online privacy. If you would like to be removed from our mailing list please reply with "Remove" in the subject and we will comply immediately. We apologize for any inconvenience caused. Please let us know if you have more than one domain. The material in this e-mail is intended only for the use of the individual to whom it is addressed and may contain information that is confidential, privileged, and exempt from disclosure under applicable law. If you are not the intended recipient, be advised that the unauthorized use, disclosure, copying, distribution, or the taking of any action in reliance on this information is strictly prohibited. We are an equal opportunity employer with a diverse workforce. Note : Any resume submitted by Siriinfo is presented with the understanding that the candidate is being considered for your direct end-client (end-client is the company where the work will be performed). If there is any other company involved between the end-client and your company, please do not submit this resume without our written approval. If you submit the resume to another third party, Siriinfo reserves the right to work with the third party directly. Keywords: rlang information technology California New Jersey North Carolina Hiring NPI Validation Engineer in Irvine, CA [email protected] |
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Wed Oct 23 21:45:00 UTC 2024 |