Regulatory Engineer Nextgen Technologies Inc. is seeking a Regulatory Engineer to support regulatory and quality compliance, engineering documentation, supplier quality management, and product conformity activities at its work location in Chillicothe, Illinois. The position focuses on evaluating non-conforming materials, reviewing engineering specifications and supplier quality records, interpreting applicable quality standards, and coordinating root cause analysis and corrective actions to support product conformity and compliance with established technical requirements.
Job Duties and Responsibilities:
Regulatory and Quality Compliance: Interpret applicable regulatory requirements, quality standards, and technical specifications to support supplier compliance, product conformity, and quality management system requirements.
Non-Conforming Material Evaluation: Review and evaluate Non-Conforming Materials (NCMs), engineering drawings, inspection records, test methods, and supplier documentation to recommend appropriate technical disposition.
Technical Documentation: Prepare, review, and maintain technical files, quality compliance records, supplier documentation, NCM reports, and Root Cause and Corrective Action (RCCA) records.
Supplier Quality Management: Coordinate with suppliers, manufacturing facilities, Supplier Development Engineers, and internal quality teams to resolve technical discrepancies and ensure compliance with applicable quality requirements.
Root Cause and Corrective Actions: Review corrective action documentation using methodologies such as 8D, 5-Why analysis, Fishbone Diagram, and Corrective and Preventive Action (CAPA) to support issue resolution and effectiveness verification.
Quality Standards and Audits: Apply relevant quality standards, including ISO 9001 and IATF 16949, and participate in supplier, internal, and external audits to support quality assurance and compliance activities.
Quality Data Analysis and Reporting: Maintain NCM logs, supplier quality databases, corrective action trackers, and supplier scorecards; analyze defect rates and supplier performance metrics to identify quality trends.
Compliance Coordination and Reporting: Prepare technical responses, quality statements, compliance reports, and corrective action updates for suppliers, facilities, customers, and other relevant stakeholders.
Required Education:
A bachelor's degree in computer science, Computer Information Systems, Management Information Systems, Industrial Management, Engineering, or a related technical field.
Required Skills and Technical Competencies:
Regulatory and Quality Compliance: Knowledge of applicable quality standards, compliance documentation, technical specifications, and product conformity requirements.
Supplier Quality Management: NCM evaluation, supplier quality records, supplier corrective actions, and supplier performance monitoring.
Root Cause Analysis: 8D, 5-Why analysis, Fishbone Diagram, CAPA, and corrective action effectiveness verification.
Quality Standards: ISO 9001, IATF 16949, APQP, PPAP, PFMEA, Control Plans, and SPC.Engineering Skills: Engineering drawing interpretation, Geometric Dimensioning and Tolerancing (GD&T), specification review, and test method evaluation.
Software and Technical Tools: Microsoft Excel, Word, PowerPoint, SharePoint, Access, and Adobe Acrobat.
Quality Systems and Databases: Familiarity with SAP, Oracle ERP/QMS systems, NCM systems, RCCA trackers, and supplier quality databases, as applicable.
Analytical and Communication Skills: Technical documentation review, quality data analysis, report preparation, problem-solving, and communication with technical stakeholders.
Equal Employment Opportunity:
Nextgen Technologies Inc. is committed to fair and nondiscriminatory employment practices. Qualified applicants will be considered in accordance with applicable employment laws.
