Quality Engineer & Lead Auditor — Regulated Systems Remote

ENERCON; San Luis Obispo (CA); Remote; USD 90,000 - 195,000; Full time

Job summary

ENERCON is expanding its Corporate Quality organization and seeking a Quality Engineer to support and strengthen our Quality Management System across a diverse and technically complex portfolio of work. This role may be based in any ENERCON office location and possibly remote within the US for senior level candidates.

You will audit internal operations, suppliers, and project execution activities, review contracts and requirements, and lead continuous improvement within a regulated environment.

Qualifications

• Bachelor's Degree in Engineering preferred; other technical degrees and equivalent experience considered.
• 3+ years of quality assurance experience in a highly regulated or engineering consulting-driven environment.
• Experience auditing engineering design packages, internal processes, and suppliers.
• Must have knowledge of standards such as 10 CFR Part 21, 10 CFR Part 50 Appendix B, ASME/ANSI NQA-1, and ISO 9001.
• Lead Auditor experience and NQA-1 Subpart 3.1 qualification preferred.
• ISO 9001 Lead Auditor certification preferred.
• Strong understanding of quality systems, auditing techniques, and corrective action processes.
• Ability to read and interpret engineering technical documents.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office and SharePoint.
• Must be a US Citizen due to federal contract requirements.

Responsibilities

• Auditing & Compliance: Plan and perform internal audits and supplier surveillances; enforce requirements and stop nonconforming work when needed.
• Contract & Requirement Review: Ensure flow-down of quality requirements in POs and contracts.
• Quality Systems & Procedures: Review and improve quality procedures; support continuous improvement.
• Corrective Action & Root Cause: Manage Corrective Action Reports and verify effectiveness.
• Cross-Functional Collaboration: Work with engineering, project management, procurement, and operations to resolve quality issues.

Skills

Auditing

Quality systems

Regulatory knowledge

Root cause analysis

Cross-functional collab

Lead Auditor

Education

Bachelor's Degree in Engineering

Tools

MS Office

SharePoint

Job description

ENERCON is expanding its Corporate Quality organization and seeking a Quality Engineer to support and strengthen our Quality Management System across a diverse and technically complex portfolio of work. This role may be based in any ENERCON office location and possibly remote within the US for senior level candidates.

You will audit internal operations, suppliers, and project execution activities, review contracts and requirements, and lead continuous improvement within a regulated environment.