| Urgent requirement NPI Validation Engineer : Irvine, CA (Onsite) at Irvine, California, USA |
| Email: [email protected] |
| From: Nitish Kumar, Quantum World Technologies Inc [email protected] Reply to: [email protected] Hello Hope you are doing well today!!! Position: NPI Validation Engineer Location: Irvine, CA (Onsite) Duration: Long term Contract Job Description: Role Description: NPI Validation, IQ, OQ, PQ, pFMEA and dFMEA Competencies: EIS : Medical Device & Regulations Experience (Years): 2-4 Essential Skills: NPI Validation Engineer3+ 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 experienceBachelor of Engineering, any specialty. Thanks & Regards, Nitish Kumar Sr. Technical Recruiter Quantum World Technologies Inc [email protected] Keywords: rlang California North Carolina Urgent requirement NPI Validation Engineer : Irvine, CA (Onsite) [email protected] |
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| Sat Oct 26 02:29:00 UTC 2024 |