Quality Engineer II (Projects)

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

Job summary

Aerogen is seeking a Quality Manufacturing professional to support manufacturing operations, new technologies and process development. You will partner with Operations and Engineering to maintain high quality and regulatory standards across projects.

Required: minimum level 8+ STEM qualification and at least five years in Quality Manufacturing within medical device or pharma sectors; experience with equipment/process validation is a plus.

Qualifications

• Minimum STEM qualification at level 8 or higher.
• Minimum 5 years Quality Manufacturing experience in medical device or pharma sectors.
• Experience implementing and validating equipment/processes is an advantage.

Responsibilities

• Provide quality support for manufacturing processes, incl. new technologies and process investigations.
• Manage process verification/validation activities and change control for project scope.
• Collaborate with Operations and Engineering to ensure quality targets and regulatory standards.
• Establish inspection plans, frequencies and test methods for incoming material/parts.
• Apply risk management (Process FMECA) to prevent failure modes and improve process capability.
• Support GMP standards and continuous improvement within Aerogen’s QMS.

Skills

Technical Expertise

Problem Solving

Results Focused

Agile Innovation

Accountability

Collaboration

Regulatory & Quality Awareness

Self-Management

Technical Tools

Education

STEM degree (level 8+)

Tools

MS Office

Minitab

Job description

About Aerogen:

Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards, including being named Galway Chamber Company of the Year 2025, and twelve-time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries.

Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work.

We lead the way by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes.

Our business continues to grow rapidly across the globe and, as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers.

What is the role?

The person in this role is responsible for supporting our manufacturing operations, new technologies and process development. Partnering with Operations, Engineering and cross-functional teams to solve problems, strengthen processes and ensure we continue to deliver products to the highest quality and regulatory standards.

What are the key responsibilities?

• Quality support at Aerogen manufacturing process including introduction of new technologies and processes, investigations of root cause analysis of quality issues in manufacturing and managing quality related NC’s in addition to addressing ongoing compliance.
• Manage Process Verification, Validation activities, change control and activities associated with commercialisation as related to the specific project scope
• Work with Operations, Engineering and cross functional teams to ensure all project teams, and process performances are delivering predetermined levels of Quality.
• Establish inspection plans, frequencies and test methods for incoming material/parts.
• Utilize appropriate risk management methodology (Process FMECA) to anticipate and prevent failure modes and help improve the capability of processes.
• Shares responsibilities for GMP standards and compliance with Aerogen’s production processes and QMS.
• Supports and leads Continuous Improvement (C.I) activities.
• Perform other assigned tasks and support all aspects of the Quality Management System as directed by the Senior Quality Manager.

What education and experience are required?

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

What key skills will make you great at the role?

• Technical Experience: Develop and apply technical expertise within your process area (e.g., inspections, test methods, validation) to support process improvements and enhance Aerogen product quality.
• Problem Solving: Apply structured problem-solving methodologies to support investigations, contribute to root cause analysis, and help identify practical and effective solutions.
• Results Focused: Deliver assigned objectives and tasks in a timely manner while working towards clear, outcome-focused goals that support team and business priorities.
• Agile Innovation with Impact: Contribute ideas and support initiatives that improve product quality, process efficiency, and overall business performance.
• Accountability: Take ownership of assigned work, follow through on deliverables, and proactively communicate progress or issues as they arise.
• Collaboration: Work effectively with cross-functional teams, communicating clearly and professionally to support problem resolution and project success.
• Regulatory & Quality Awareness: Apply a working knowledge of medical device manufacturing and relevant standards and regulations (EN ISO 13485:2016, EU-MDR, MDSAP, FDA) to support compliant processes and quality outcomes.
• Self-Management: Operate as a motivated self-starter capable of managing responsibilities in a dynamic environment while seeking guidance when appropriate.
• Technical Tools: Utilize Microsoft Office and statistical tools such as Minitab to analyse data and support process monitoring and improvement activities.

What is it like to work at Aerogen?

Our purpose is to transform patients' lives and innovation is embedded in our culture. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:

• Excellent medical care.
• Bonus & Pension.
• ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
• We pledge 1% of profits and time to charities and organisations.

Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing [e-mail]. Please include your name and preferred method of contact.