| NPI Validation Engineer || Location: Irving, TX at Irving, Texas, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2232152&uid= From: Khayal Abbas, Scalable-Systems [email protected] Reply to: [email protected] Job Title: NPI Validation Engineer Location: Irving, TX (Onsite) Company: TCSJob Summary: We are seeking an experienced NPI Validation Engineer with expertise in New Product Introduction (NPI), product validation, and quality management systems (QMS). The ideal candidate will support product and equipment validation, risk management (pFMEA, dFMEA), and compliance with ISO 13485 and FDA 21 CFR Part 820.Key Responsibilities: Perform and document technical functions related to test, quality control, fabrication, and assembly. Conduct validation of product and equipment to ensure compliance with regulatory standards. Support New Product Introduction (NPI) using SolidWorks and Windchill PLM. Implement and oversee risk management processes (pFMEA, dFMEA). Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and GMP regulations. Contribute to audits, NC, CAPA processes, and maintain QMS using ETQ Instinct. Work with JnJ tools such as ADAPTIV and Windchill PLM.Required Skills: 3+ years of experience in New Product Introduction, Validation, and QMS. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP. Experience in pFMEA, dFMEA, and risk management. Proficiency in SolidWorks and Windchill PLM.Preferred Skills: Experience with ETQ Instinct, ADAPTIV, and regulatory audits. Background in medical device manufacturing. Keywords: North Carolina Texas NPI Validation Engineer || Location: Irving, TX [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2232152&uid= |
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| 06:05 AM 06-Mar-25 |