Quality Engineer I (1 Year FTC)

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 Quality Engineer I is responsible for quality engineering activities for manufacturing processes, materials, and products as well as within Project Teams. Other activities may be assigned as needed.

What are the key responsibilities?
The position requires the person to take the lead in the following areas of Quality:

• Support of Manufacturing process changes and improvements including Quality Inspection at different points in the process.
• Material Review Board (MRB) system and material control Incoming Inspection System and process.
• NC/CAPA ownership and closure.
• Work alongside cross functional teams to complete appropriate continuous improvement initiatives.
• Process Quality Control to ensure all product meets its requirements prior to shipment.
• Corrective Action activities related to manufacturing process and systems.
• 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.
• Perform other assigned tasks and support all aspects of the Quality System as directed.

What education and experience are required?

• BE/BS Degree or related discipline.
• At least 1-3 years Quality Engineering experience or related role within the medical device industry.

What key skills will make you great at the role?

• 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. Theres 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.