Quality Engineer & Lead Auditor – Regulated Systems

ENERCON; Cahaba Commons (AL); Remote; USD 90,000 - 195,000; Full time

Job summary

ENERCON is expanding its Corporate Quality organization and seeks a Quality Engineer to support the Quality Management System across a technically complex portfolio. The role embeds quality into project inception through execution, with emphasis on auditing operations, suppliers, and project activities.

The ideal candidate has 3+ years in quality assurance within regulated environments, ISO 9001 Lead Auditor experience, and the ability to influence quality at an enterprise level through

Qualifications

• 3+ years of quality assurance experience in a highly regulated or engineering consulting-driven environment.
• Experience auditing engineering design packages, internal processes, and suppliers.
• Lead Auditor certification or experience is highly preferred.
• Knowledge of 10 CFR Part 21, 10 CFR Part 50 Appendix B, ASME/ANSI NQA-1, and ISO 9001.

Responsibilities

• Auditing internal operations, suppliers, and project execution activities.
• Review purchase orders, contracts, task orders, and agreements to ensure quality requirements flow-down.
• Review, revise, and improve quality procedures supporting the QMS and project management.
• Prepare, issue, and manage Corrective Action Reports and verify their effectiveness.
• Collaborate with engineering, project management, procurement, and operations to resolve quality issues.

Skills

Auditing

Contract & Requirement Review

Quality Systems & Procedures

Corrective Action & Root Cause

Cross-Functional Collaboration

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

SharePoint

Job description

ENERCON is expanding its Corporate Quality organization and seeks a Quality Engineer to support the Quality Management System across a technically complex portfolio. The role embeds quality into project inception through execution, with emphasis on auditing operations, suppliers, and project activities.

The ideal candidate has 3+ years in quality assurance within regulated environments, ISO 9001 Lead Auditor experience, and the ability to influence quality at an enterprise level through