Quality Engineer & Lead Auditor (Regulated)

Enercon Services, Inc.; Chattanooga (TN); On-site; USD 90,000 - 145,000; Full time

Job summary

Enercon Services, Inc. is seeking a Quality Engineer to bolster its Quality Management System across a diverse portfolio.

The role can be based in any Enercon office or remotely within the US for senior candidates, embedding quality into processes from inception through execution. The position emphasizes audits of internal operations and suppliers, driving continuous improvement and compliance with standards such as 10 CFR Part 21 and ISO 9001.

Qualifications

• Bachelor’s degree in engineering or a scientific field.
• 6+ years of quality assurance in regulated/engineering environments.
• Experience auditing design packages and suppliers.
• Knowledge of 10 CFR Part 21, 10 CFR Part 50 Appendix B, ASME/ANSI NQA-1, ISO 9001.
• Lead Auditor experience; NQA-1 Subpart 3.1 preferred.
• ISO 9001 Lead Auditor certification preferred.
• Strong quality systems, auditing techniques, corrective actions.
• Ability to read engineering documents.
• Excellent written and verbal communication.
• US Citizenship required due to federal contract

Responsibilities

• Auditing & Compliance: Plan and perform internal audits and external supplier audits and surveillances as a certified Lead Auditor. Exercise independent judgment to enforce requirements and stop nonconforming work when necessary
• Contract & Requirement Review: Review purchase orders, contracts, task orders, and agreements to ensure appropriate flow-down of quality requirements
• Quality Systems & Procedures: Review, revise, and improve quality procedures supporting the quality system, engineering, and project management. Support continuous improvement of ENERCON’s Quality Management System and Quality Assurance Program
• Corrective Action & Root Cause: Prepare, issue, and manage Corrective Action Reports using ENERCON’s Performance Tracking System. Perform or support causal analysis and verify corrective action effectiveness
• Cross-Functional Collaboration: Collaborate with engineering, project management, procurement, and operations teams to resolve quality issues

Skills

Auditing

Quality assurance

Technical reading

Communication skills

Education

Bachelor’s Degree in Engineering or a scientific discipline

Tools

Microsoft Office

SharePoint

Job description

Enercon Services, Inc. is seeking a Quality Engineer to bolster its Quality Management System across a diverse portfolio.

The role can be based in any Enercon office or remotely within the US for senior candidates, embedding quality into processes from inception through execution. The position emphasizes audits of internal operations and suppliers, driving continuous improvement and compliance with standards such as 10 CFR Part 21 and ISO 9001.