Quality Engineer: Lead Auditor for Regulated Environments

ENERCON

King of Prussia (PA)

On-site

USD 90,000 - 145,000

Full time

14 days+

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Job summary

ENERCON is expanding its Corporate Quality organization and seeks a Quality Engineer to strengthen our Quality Management System. The role supports a complex portfolio and may be remote within the US for senior candidates.

The successful candidate will lead audits, review contracts for quality requirements, and drive continual improvement across engineering, procurement, and operations. A strong QA background in regulated environments is essential.

Qualifications

6+ years of quality assurance experience in a highly regulated or engineering consulting-driven environment.
Experience auditing engineering design packages, internal processes, and suppliers.
ISO 9001 Lead Auditor certification is highly preferred.

Responsibilities

Auditing & Compliance: Plan and perform internal audits and supplier audits; enforce requirements and stop nonconforming work.
Contract & Requirement Review: Ensure flow-down of quality requirements in POs, contracts, and agreements.
Quality Systems & Procedures: Review and improve quality procedures; support QMS and QA program.
Corrective Action & Root Cause: Prepare and manage Corrective Action Reports; perform causal analysis.
Cross-Functional Collaboration: Work with engineering, project management, procurement, and operations to resolve quality issues.