Senior Supplier Quality Engineer - QA & Supplier Excellence

Cintrifuse; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Enable Injections Inc. seeks a Supplier Quality professional to support qualification and maintenance of suppliers within a robust QMS framework. This role collaborates with cross-functional teams to drive Quality Actions and maintain supplier network integrity.

Ideal candidates have a strong background in FDA-regulated environments, ISO standards, and PV/navigation processes, with excellent written communication and problem-solving skills. Some travel may be required.

Qualifications

• Bachelor's degree in Science, Health, or Engineering required.
• Minimum 6 years in a supplier-facing role with an established QMS.
• Minimum 6 years in an FDA-regulated environment.
• Experience with ISO9001, ISO13485, ISO17025 or related standards.
• Experience with 21 CFR 210, 211, or 820.
• Experience with DQ/IQ/OQ/PQ and PV navigation.
• Auditor certification or auditor experience preferred.
• Experience with controlled environments, cleanrooms or clean spaces preferred.

Responsibilities

• Maintain oversight of the Approved Supplier List (ASL) and drive continuous improvement of ASL activities.
• Provide guidance on supplier qualification pathways in line with site procedures.
• Lead SCARs and Quality Alerts with Enable and suppliers for robust documentation and closure.
• Support and lead on-site or remote Quality audits and documentation.
• Lead supplier evaluation and performance documentation (e.g., Supplier Scorecards).
• Apply risk-based assessments for supplier classification (GxP) when evaluating new/approved suppliers.
• Create and revise procedures to support Supplier Management and Enable.
• Drive CAPAs, Nonconformances, Audits, Change Control, and other QMS elements.
• Ensure accuracy and traceability of supplier documentation in physical and electronic systems (e.g., SAP).
• Provide routine updates to department leadership and escalate supplier-related challenges.
• Develop collaborative relationships with the Enable supplier network for continuous improvement.

Skills

SCAR navigation

CAPA navigation

RCA

Quality Audits

Change Control

Technical Writing

Cross-functional collaboration

Time management

Education

Bachelor's Degree in Science, Health, or Engineering

Job description

Enable Injections Inc. seeks a Supplier Quality professional to support qualification and maintenance of suppliers within a robust QMS framework. This role collaborates with cross-functional teams to drive Quality Actions and maintain supplier network integrity.

Ideal candidates have a strong background in FDA-regulated environments, ISO standards, and PV/navigation processes, with excellent written communication and problem-solving skills. Some travel may be required.