Quality Engineer & Lead Auditor for Regulated Environments

ENERCON

Emeryville (CA)

On-site

USD 90,000 - 145,000

Full time

14 days+

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Job summary

ENERCON is seeking a Quality Engineer to strengthen our Quality Management System across a complex portfolio. The role emphasizes auditing internal operations, suppliers, and project activities, with seniority allowing remote work within the US.

Ideal candidates bring 6+ years in regulated or engineering consulting environments, Lead Auditor experience, and strong capability to influence enterprise quality decisions. This is a full-time, US-based position with a comprehensive QA focus.

Qualifications

Bachelor's degree in engineering required.
6+ years QA experience 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, ISO 9001.
Lead Auditor with NQA-1 Subpart 3.1 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 communication.

Responsibilities

Auditing & Compliance: plan and perform internal and supplier audits; stop nonconforming work when necessary.
Contract & Requirement Review: ensure flow-down of quality requirements in PO/contracts.
Quality Systems & Procedures: review and improve quality procedures; support QMS and QA program.
Corrective Action & Root Cause: manage CAPAs and verify effectiveness.
Cross-Functional Collaboration: work with engineering, project management, procurement, and operations.