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 Supplier Quality Engineer I is responsible for leading quality engineering activities within supplier controls and project teams, in addition to the monitoring, approval and qualification of existing and new suppliers whilst managing all process validations. Other activities may be assigned as needed.
What are the key responsibilities?
- Appropriately train, develop and manage resources within Supplier Quality Team to ensure objectives are communicated and delivered within agreed requirements.
- Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
- Demonstrate strong leadership and a clear identifiable work ethos within the Supplier quality engineering team.
- Work with the Supplier Quality Group to lead engagement with Aerogen's critical Suppliers with Regards to EU MDR compliance.
- Manage and lead all process validation activities including IQ, QQ and PQ with exiting and new Suppliers.
- Ensure effective and timely closure of Quality System documentation (Audit Actions, SCAR's, SCN's, PAN's, etc.).
- Build strong relationships with suppliers (inclusive of 3rd party logistic providers and distributors) focusing on strong collaboration, communications, and monitoring/planning activities whilst establishing agreements to appropriately address regulatory and quality obligations and responsibilities.
- Lead Quality Engineering support at Aerogen on project activities i.e.: Design Improvements, Supplier Transfer's Cost Improvements, and New Product Introductions etc.
- Lead Supplier Approval and Supplier Management Activities and manage Supplier Quality assurance process for allocated Suppliers to ensure Aerogen Supplier Approval Requirements are met.
- Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts.
- Champion continuous process improvement and, in conjunction with other functions, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
- Overall responsibility of GMP standards and compliance within Aerogen's Project Teams and Supplier Engagement.
- Maintain compliance with ISO and FDA Quality System regulations.
What education and experience are required?
- BE/BS Degree.
- A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
- At least six 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 work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.
- 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 and with suppliers.
- Process Validation knowledge and leadership ability.
- Good administrative/organisational ability with high level of attention to detail.
- Ability to liaise with suppliers, customers and regulatory contacts in an informed processional manner.
- Thorough understanding of ISO 13485 and FDA QSR standards.
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.
