What are the responsibilities and job description for the Manufacturing Quality Engineer – NPI Validation Engineer position at Accuro?
Role: Manufacturing Quality Engineer – NPI Validation Engineer
Duration: 12 Months
Location - IRVING, TX
Role name: Engineer
Role Description: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA
Competencies: EIS : Medical Device & Regulations, EIS : New Product Development (NPD) Methodology and Management
Experience (Years): 2-4
Essential Skills:
• 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
Desirable Skills: A Minimum bachelor’s degree in engineering, Science or related technical field3 years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred
Keywords: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA
Thanks & Regards,
Beauty Rani |ACCURO GROUP|
Direct: 919-676-8033
EMAIL beauty.r@accurogroup.com
