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Supplier Quality Engineer - Distributor & 3PL

About Aerogen: 
Headquartered in the vibrant city of Galway, 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 16 million patients in over 75 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 Supplier Quality Engineer – Distribution & 3PL will provide Quality Assurance support to the monitoring, approval and qualification of suppliers, distributors and third-party logistic providers.

What are the key responsibilities? 
 
• Support the selection, development, and management of new suppliers, distributors and 3PL providers to ensure Aerogen Supplier & Distributor Approval Requirements are met. 
• Engage with Suppliers, Distributors and 3PL providers on root cause investigation when issues arise and with change notifications raised by Aerogen on these parties. 
• Collaborate with Distributors & 3PL suppliers to establish quality agreements which will appropriately address regulatory and quality obligations and responsibilities in addition to managing the expectations of the two parties involved. 
• Participate in business reviews with Distributors, 3PL providers and suppliers providing key QA Inputs and cross functional team engagement.
• Build strong relationships with Distributors, 3PL’s and suppliers focusing on strong collaboration, communications, and planning activities. 
• Support the implementation of and maintain compliance to supplier, Distributor and 3PL EU MDR requirements with key interaction with Aerogen’s Regulatory Affairs Department.
• Manage and drive continuous improvement activities focusing on quality assurance in the areas of supplier, distributor and third-party logistics management.
• Maintain compliance with ISO, FDA Quality System regulations and other applicable worldwide regulations pertaining to the business.

What education and experience are required?  
• A minimum of a degree in a Quality/Engineering/Science or related discipline. 
• At least four years Quality Engineering/Assurance experience or related role preferably within the medical device industry

What key skills will make you great at the role? 
• Excellent planning and coordination skills. 
• Effective verbal and written communication skills. 
• Strong attention to detail. 
• A dynamic team player can work effectively and proactively on cross-functional teams.
• Ability to work on own initiative. 
• Qualified Lead Auditor, preferably within the Medical Device Industry desirable. 
• Demonstrate and actively promote high levels of professional quality engineering/quality assurance. 
• Ability to liaise with suppliers, 3rd parties, customers and regulatory contacts in an informed professional manner. 
• Thorough understanding of ISO 13485, ISO14971, the FDA QSR standards and the Medical Device Directive, EU Medical Device Regulation 2017/745.
• Flexibility to travel when required.

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. 


Location
Ireland - Head Office (B2)

Department
QA/RA

Job Title
Supplier Quality Engineer - Distributor & 3PL

Salary

Experience

City
Galway

Country
Ireland