Quality Engineer - Lead Auditor, QMS & Compliance

ENERCON; King of Prussia (PA); Remote; USD 90,000 - 195,000; Full time

Job summary

ENERCON is expanding its Corporate Quality organization and seeks a Quality Engineer to strengthen our Quality Management System across a diverse portfolio. The role can be based in any ENERCON office and possibly remote within the US for senior candidates.

The position emphasizes auditing internal operations, suppliers, and project execution activities, with preference for nuclear quality experience but open to regulated environments.

Qualifications

• Bachelor's Degree in Engineering preferred or equivalent experience.
• 3+ years QA experience in regulated/engineering environments.
• Experience auditing engineering design packages, processes, and suppliers.
• Lead Auditor certification or experience is highly valued.
• Knowledge of 10 CFR Part 21, 10 CFR Part 50 Appendix B, ASME/ANSI NQA-1, ISO 9001.

Responsibilities

• Plan and perform internal and supplier audits and surveillance as a Lead Auditor.
• Review POs, contracts, task orders to ensure proper flow-down of quality requirements.
• Review and improve quality procedures supporting QMS and project management.
• Prepare and manage Corrective Action Reports and verify effectiveness.
• Collaborate with engineering, project management, procurement, and operations to resolve quality issues.

Skills

Quality assurance

Auditing

Lead Auditor

Cross-functional collab

Communication

Education

Bachelor's degree in Engineering

NQA-1 Lead Auditor

ISO 9001 Lead Auditor

Tools

Microsoft Office

SharePoint

Job description

ENERCON is expanding its Corporate Quality organization and seeks a Quality Engineer to strengthen our Quality Management System across a diverse portfolio. The role can be based in any ENERCON office and possibly remote within the US for senior candidates.

The position emphasizes auditing internal operations, suppliers, and project execution activities, with preference for nuclear quality experience but open to regulated environments.