Senior Supplier Quality Engineer II — Supplier Excellence

Aerogen; Galway; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Aerogen, based in Galway, Ireland, seeks a Senior Supplier Quality Engineer II to lead technical and quality engineering activities with external suppliers, ensuring products and services meet Aerogen’s requirements.

You will build supplier relationships, lead supplier approvals, drive CAPA, perform IQ/OQ/PQ validation, and implement continuous quality improvements while maintaining GMP compliance across project teams.

Qualifications

• At least 8 years’ equivalent experience in Engineering, Process Development or Manufacturing Environment.
• Minimum of a primary degree in Engineering or related technical field.

Responsibilities

• Train and mentor Supplier Quality Team members to meet requirements.
• Build strong supplier relationships with clear collaboration and compliance obligations.
• Lead supplier approval and qualification activities to ensure quality and regulatory compliance.
• Oversee CAPA, audit actions, SCARs, SCNs, PANs and related corrective actions.
• Lead supplier validation activities (IQ/OQ/PQ) in major Aerogen projects.
• Drive continuous improvement of Supplier Quality processes and digital solutions.
• Collaborate with crossfunctional teams to establish inspection plans and test methods.
• Monitor supplier performance metrics and drive data-driven improvements.
• Promote Six Sigma and statistical techniques to enhance product quality and process efficiency.
• Ensure GMP standards and regulatory compliance across project teams.

Skills

Initiative

Quality improvement

Teamwork

Communication

Problem solving

Data analysis

Process validations

Gauge R&R

Regulatory liaison

Attention to detail

Education

Engineering degree

Tools

GMP systems

Job description

Aerogen, based in Galway, Ireland, seeks a Senior Supplier Quality Engineer II to lead technical and quality engineering activities with external suppliers, ensuring products and services meet Aerogen’s requirements.

You will build supplier relationships, lead supplier approvals, drive CAPA, perform IQ/OQ/PQ validation, and implement continuous quality improvements while maintaining GMP compliance across project teams.