Quality Assurance Lead – Regulated Engineering Audits

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

Job summary

Enercon Services, Inc. is expanding its Corporate Quality organization and seeks a Quality Engineer to strengthen the Quality Management System across a diverse portfolio.

This role emphasizes auditing internal operations, suppliers, and project activities from inception through execution, with remote options within the US for senior candidates. The ideal candidate has 6+ years in regulated QA or engineering consulting, Lead Auditor experience, and familiarity with 10 CFR Part 21/50, ISO 9001,

Qualifications

• Bachelor’s Degree in Engineering or a scientific discipline or equivalent experience.
• 6+ years of QA experience in regulated or engineering consulting environments.
• Experience auditing engineering design packages and internal processes.
• Knowledge of 10 CFR Part 21, 10 CFR Part 50 Appendix B, ASME/ANSI NQA-1, ISO 9001.
• Lead Auditor experience; NQA-1 qualification and ISO 9001 Lead Auditor preferred.
• Strong auditing, corrective action, and written/verbal communication skills.

Responsibilities

• Plan and perform internal audits and supplier audits; exercise independent judgment to enforce requirements.
• Review contracts and purchase orders for proper flow-down of quality requirements.
• Review and improve quality procedures; support QMS and QA programs.
• Prepare and manage Corrective Action Reports; analyze root causes and verify effectiveness.
• Collaborate with engineering, project management, procurement, and operations to resolve quality issues.

Skills

Lead Auditor

Auditing techniques

Quality systems

Regulatory compliance

Communication skills

Read engineering docs

Education

Bachelor’s Degree in Engineering or scientific discipline

Job description

Enercon Services, Inc. is expanding its Corporate Quality organization and seeks a Quality Engineer to strengthen the Quality Management System across a diverse portfolio.

This role emphasizes auditing internal operations, suppliers, and project activities from inception through execution, with remote options within the US for senior candidates. The ideal candidate has 6+ years in regulated QA or engineering consulting, Lead Auditor experience, and familiarity with 10 CFR Part 21/50, ISO 9001,