MedTech Quality Engineer II — Process Excellence

Aerogen Ltd.; Galway; Remote; EUR 65,000 - 90,000; Full time

Job summary

Aerogen in Galway, Ireland, a world leader in acute care aerosol drug delivery, seeks a Quality Manufacturing professional to support manufacturing operations and process development. You will partner with Operations and Engineering to solve problems, validate equipment, drive continuous improvement, and ensure compliance with EN ISO 13485:2016, EU-MDR, MDSAP and FDA standards.

The role requires a STEM degree and at least five years in Quality Manufacturing within medical devices or pharma, with

Qualifications

• Minimum level 8 or higher STEM qualification.
• At least five years of Quality Manufacturing experience in medical device or pharma.
• Experience implementing and validating equipment and processes is a plus.

Responsibilities

• Quality support at Aerogen manufacturing processes, including new technologies and NC management.
• Manage Process Verification, Validation, and change control activities for projects.
• Collaborate with Operations, Engineering and cross functional teams to meet predefined Quality levels.
• Establish inspection plans, frequencies and test methods for incoming materials.
• Apply risk management (Process FMECA) to prevent failures and improve processes.
• Support GMP standards and QMS compliance.
• Lead Continuous Improvement (CI) activities.
• Perform tasks as directed by the Senior Quality Manager.

Skills

Technical Experience

Problem Solving

Results Focused

Agile Innovation

Accountability

Collaboration

Regulatory & Quality Awareness

Self-Management

Technical Tools

Education

Minimum level 8 or higher STEM Qualification

Tools

Microsoft Office

Minitab

Job description

Aerogen in Galway, Ireland, a world leader in acute care aerosol drug delivery, seeks a Quality Manufacturing professional to support manufacturing operations and process development. You will partner with Operations and Engineering to solve problems, validate equipment, drive continuous improvement, and ensure compliance with EN ISO 13485:2016, EU-MDR, MDSAP and FDA standards.

The role requires a STEM degree and at least five years in Quality Manufacturing within medical devices or pharma, with