Senior Supplier Quality Engineer

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Enable Injections Inc. seeks a Senior Engineer, Supplier Quality to support the supplier network and QMS elements. You will qualify and maintain suppliers, collaborate cross-functionally, and drive quality actions.

The role requires a minimum of six years in supplier-facing, regulated environments, with ISO and CFR experience, and strong documentation and cross-functional communication skills. On-site Cincinnati area preferred.

Qualifications

• Bachelor's degree in Science, Health, or Engineering.
• Minimum 6 years in a supplier-facing role within a QMS environment.
• Minimum 6 years in an FDA or other regulated environment.
• Experience with ISO 9001, ISO 13485, ISO 17025 or similar.

Responsibilities

• Maintain oversight of supplier qualification and continuous ASL improvement.
• Lead SCARs and Quality Alerts with suppliers and Enable team for robust closure.
• Schedule and document on-site and remote Quality audits.
• Lead supplier evaluation and performance documentation (e.g., scorecards).
• Apply risk-based assessment for Critical/Major/Minor supplier classifications.
• Create and revise procedures to support Supplier Management and Enable.

Skills

SCAR navigation

CAPA navigation

Root Cause Analysis

Quality Audit response

Change Control navigation

Technical Writing

Cross-functional cooperation

Business acumen

Integrity in supplier management

Education

Bachelor’s Degree in Science/Health/Engineering

Tools

SAP

Job description

Enable Injections Inc. seeks a Senior Engineer, Supplier Quality to support the supplier network and QMS elements. You will qualify and maintain suppliers, collaborate cross-functionally, and drive quality actions.

The role requires a minimum of six years in supplier-facing, regulated environments, with ISO and CFR experience, and strong documentation and cross-functional communication skills. On-site Cincinnati area preferred.