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Production Quality Engineer
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Avc
Newark, DE (In Person)
$88,400 Salary, Full-Time
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Job Description
Candidates without hands-on electro-mechanical troubleshooting experience will not be considered. Supplier Quality Engineer Newark, Delaware | 12-Month Contract | 100% Onsite.
Saturday availability is mandatory This role is 100% onsite in Newark, DE. Overview We are hiring a hands-on Quality Engineer to support our medical device production line in Newark, DE. This role focuses on electro-mechanical troubleshooting, supplier quality, and rapid resolution of non-conformances within a strict GMP/cGMP-regulated environment. You will work directly on the production floor, lead investigations, manage supplier NCEs, and maintain quality records to support audits and continuous improvement. Key responsibilities Lead NCE investigations from initiation through closure, execute containment actions, and maintain records in Agile PLM. Trace affected inventory using Oracle Inventory Management, warehouse stock records, and incoming inspection data to determine material disposition. Partner with production, manufacturing engineering, supplier quality, and procurement to resolve quality issues in real time and support CAPA. Perform risk assessments for quality escapes and execute containment activities across supplier and manufacturing nonconformances (typically 10-15 NCEs weekly). Ensure GMP/cGMP compliance in all quality activities and maintain documentation to support regulatory audits and inspections. Troubleshoot electro‑mechanical device defects on the production floor; author and review rework procedures for non-conforming product. Audit Device History Records (DHRs) for errors and compliance gaps; read and interpret engineering drawings, BOMs, schematics, and assembly procedures. Drive continuous improvement initiatives tied to product quality and line efficiency using data analysis (Python, Excel). Required qualifications 3+ years of hands-on electro-mechanical troubleshooting experience — non-negotiable. Experience working in a regulated manufacturing environment (medical device experience preferred). Practical knowledge of
Saturday availability is mandatory This role is 100% onsite in Newark, DE. Overview We are hiring a hands-on Quality Engineer to support our medical device production line in Newark, DE. This role focuses on electro-mechanical troubleshooting, supplier quality, and rapid resolution of non-conformances within a strict GMP/cGMP-regulated environment. You will work directly on the production floor, lead investigations, manage supplier NCEs, and maintain quality records to support audits and continuous improvement. Key responsibilities Lead NCE investigations from initiation through closure, execute containment actions, and maintain records in Agile PLM. Trace affected inventory using Oracle Inventory Management, warehouse stock records, and incoming inspection data to determine material disposition. Partner with production, manufacturing engineering, supplier quality, and procurement to resolve quality issues in real time and support CAPA. Perform risk assessments for quality escapes and execute containment activities across supplier and manufacturing nonconformances (typically 10-15 NCEs weekly). Ensure GMP/cGMP compliance in all quality activities and maintain documentation to support regulatory audits and inspections. Troubleshoot electro‑mechanical device defects on the production floor; author and review rework procedures for non-conforming product. Audit Device History Records (DHRs) for errors and compliance gaps; read and interpret engineering drawings, BOMs, schematics, and assembly procedures. Drive continuous improvement initiatives tied to product quality and line efficiency using data analysis (Python, Excel). Required qualifications 3+ years of hands-on electro-mechanical troubleshooting experience — non-negotiable. Experience working in a regulated manufacturing environment (medical device experience preferred). Practical knowledge of