Quality Engineer II — MedTech Manufacturing & CI

Aerogen; Galway; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Excellent medical care

Bonus & Pension

Aerogen Connect

Job summary

Aerogen, headquartered in Galway, Ireland, is a world leader in acute care aerosol drug delivery. The Quality Manufacturing role supports manufacturing operations, new technologies, and process development to sustain high quality and regulatory compliance across global sites.

The successful candidate will apply robust problem solving, process validation, and risk management skills within a dynamic, cross-functional team.

Qualifications

• Minimum level 8 or higher STEM Qualification.
• Minimum of five years Quality Manufacturing experience in the medical device or pharma sectors.
• Demonstrated experience in implementing and validating equipment and processes is advantageous.

Responsibilities

• Quality support for manufacturing processes, including new technologies and process investigations.
• Manage process verification, validation, and change control for project scopes.
• Collaborate with Operations, Engineering and cross-functional teams to ensure quality targets are met.
• Establish inspection plans, frequencies and test methods for incoming material/parts.
• Apply risk management methods to anticipate and prevent failure modes and improve process capability.
• Support GMP standards and compliance within Aerogen’s production processes and QMS.
• Lead or support Continuous Improvement activities.
• Assist and report to the Senior Quality Manager on assigned tasks.

Skills

Quality Manufacturing

Root Cause Analysis

GMP Compliance

Process Validation

Cross-functional Collaboration

Regulatory Awareness

Education

Bachelor’s degree in STEM

Tools

Minitab

Microsoft Office

Job description

Aerogen, headquartered in Galway, Ireland, is a world leader in acute care aerosol drug delivery. The Quality Manufacturing role supports manufacturing operations, new technologies, and process development to sustain high quality and regulatory compliance across global sites.

The successful candidate will apply robust problem solving, process validation, and risk management skills within a dynamic, cross-functional team.