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. 
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What is the role?   
The person in this role is responsible for ensuring that all quality documentation associated with the functional, visual and dimensional testing is completed in accordance with established procedures and current DHR requirements. In addition, until additional FAB lines are installed, (three lines are planned in total), this individual will also be trained to perform established Technician responsibilities for ancillary processes, i.e. IB,SMT, Moulding etc. However, primary responsibilities will be the FAB process.

What are the key responsibilities?   
• MRB (Materials Review Board) system and material control.
• Support of Manufacturing process changes and improvements including Quality Inspection at different points in the process.
• Process Quality Control to ensure all products meet its requirements prior to shipment including in process and final inspections.
• Corrective Action activities related to manufacturing process and associated systems NC. CAPA.
• Identifying any potential trends during failure analysis and initiating improvement initiatives.
• Trending and reporting on the Key Quality and Performance Objectives for manufacturing quality.
• Maintain compliance with ISO and FDA Quality System regulations.
• The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary.
• The role will require a high degree of flexibility to coordinate the variety of tasks.

What education and experience are required? 
• A minimum of a certificate (Level 6 NFQ) in a Quality/Science or related discipline.
• At least 2/3 years practical and relevant experience working in a Medical Device Operations environment.

What key skills will make you great at the role?  
• A ‘self-starter’ in terms of time and task management and operate with minimal supervision.
• Strong problem-solving ability. 
• Good communicator both verbally and in writing with ability to influence.
• Ability to meet deadlines.
• Good understanding of ISO 13485 and FDA QSR quality standards.
• Proficiency in use of desktop software applications such as MS Office.
• A good Team player who exhibits Aerogen’s Values and beliefs on a daily basis.
• Proven ability to be able to follow and interpret Process flow schematics, drawings and DHR’s.

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.