Senior Quality Engineer & Lead Auditor (Regulated Eng)

ENERCON; Cahaba Commons (AL); On-site; USD 90,000 - 145,000; Full time

Job summary

ENERCON is expanding its Corporate Quality organization and seeking a Quality Engineer to support ENERCON's Quality Management System. The role can be based in any ENERCON office or remote within the US for senior candidates.

The ideal candidate will have 6+ years in regulated environments, experience auditing design packages and suppliers, and strong QA knowledge of standards such as 10 CFR Part 21, ISO 9001, and NQA-1. US citizenship is required.

Qualifications

• Bachelor's degree in engineering required.
• 6+ years in quality assurance in regulated or engineering consulting environments.
• Experience auditing engineering design packages, internal processes, and suppliers.
• Knowledge of 10 CFR Part 21, 10 CFR Part 50 Appendix B, ASME/ANSI NQA-1, and ISO 9001.
• Lead Auditor experience and NQA-1 / ISO 9001 certifications preferred.
• Strong understanding of QA systems, auditing techniques, and corrective actions.
• US Citizenship required due to federal contract.

Responsibilities

• Auditing & Compliance: Plan and perform internal audits and external supplier audits and surveillances; enforce requirements and stop nonconforming work.
• Contract & Requirement Review: Review purchase orders, contracts, task orders, and agreements to ensure flow-down of quality requirements.
• Quality Systems & Procedures: Review, revise, and improve quality procedures; support continuous improvement of ENERCON's QMS and QA program.
• Corrective Action & Root Cause: Prepare, issue, and manage Corrective Action Reports; perform causal analysis and verify effectiveness.
• Cross-Functional Collaboration: Collaborate with engineering, project management, procurement, and operations to resolve quality issues.

Skills

Lead Auditor experience

Regulatory standards understanding

US Citizen

Auditing knowledge

Communication skills

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

SharePoint

Job description

ENERCON is expanding its Corporate Quality organization and seeking a Quality Engineer to support ENERCON's Quality Management System. The role can be based in any ENERCON office or remote within the US for senior candidates.

The ideal candidate will have 6+ years in regulated environments, experience auditing design packages and suppliers, and strong QA knowledge of standards such as 10 CFR Part 21, ISO 9001, and NQA-1. US citizenship is required.