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 and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries. 
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, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. 
Our business is growing 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. Join us as we continue to #discoverbetter. 

What is the role?   
The Senior Quality Engineer I, reporting to the Quality Manager, is a key member of the Manufacturing Quality group. Responsible for maintaining high-quality standards in their area, the successful candidate will drive quality engineering activities for manufacturing processes, materials, and products whilst leading the relevant resources as part of a team.

What are the key responsibilities?   
• Demonstrate strong leadership and a clear identifiable work ethos within the Quality Engineering Team.
• Lead Quality Engineering support at Aerogen manufacturing process driving process continuous improvements and providing manufacturing support, this includes:
   •Process/manufacturing data analysis, trending, and assisting yield reporting. 
   • Investigation root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s.
   • Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk.
   • Lead the Materials Review Board (MRB) process.
   • Address ongoing compliance
• Establish inspection plans, frequencies and test methods for incoming material/parts.
• Appropriately train, develop and manage resources within the Quality Engineering support team to ensure objectives are communicated and delivered within agreed requirements.
• Ensure effective and timely closure of Quality system documentation (Audit Actions, NC’s, CAPA’s, Reject Report’s etc)
Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
• Overall responsibility for GMP standards and compliance within Aerogen’s manufacturing area
• Drive risk management activities in manufacturing (Process FMECA).
• Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.
• Maintain compliance with ISO and FDA Quality System regulations.
• Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.

What education and experience are required?   
• BE/BS Degree
• At least eight years Quality Engineering experience or related role within the medical device industry 

​What key skills will make you great at the role?  
• Experience of leading and managing teams
• Ability to work on own initiative.
• Strong team member with the ability to identify and drive implementation of innovative quality 
improvements
• Ability to consistently meet deadlines
• Demonstrate and actively promote high levels of professional quality engineering
• Good communication skills. Must have the ability to communicate effectively at all levels of the company
• Ability to write clear, concise technical protocols and reports.
• Good administrative/organizational ability with high level of attention to detail
• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner
• Thorough understanding of ISO 13485 and FDA QSR 

What is it like to work at Aerogen?   
Our purpose is to transform patient lives, and our ethos is to #discoverbetter. 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

Check out our careers website to discover more about Life at Aerogen

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 careers@aerogen.com. Please include your name and preferred method of contact.