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Role: Validation Engineer
Location: IRVING, TX (Onsite)
Job Description:
NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA
• 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
Sagar Bhardwaj
Sr. Technical Recruiter
300 Alexander Park |Suite #200|Princeton , NJ 08540
Office: +1 7324521006 Ext238
Email: [email protected]| URL: http://www.diverselynx.com