Overview
Headquartered in Galway, Ireland, Aerogen is a world leader in acute care aerosol drug delivery.
We are recognized with MedTech awards and the Zenith award for Respiratory Care Excellence in North America, and our solutions have reached 20 million patients in over 80 countries.
We value collaboration, innovation, and delivering better patient care through continuous improvement and teamwork.
We invite you to join us as we continue to
#discoverbetter.
What is the role?
The Supplier Quality Engineer II works with external suppliers and cross-functional teams on a daily basis to resolve supplier-related issues, lead supplier activities within projects, drive continuous improvement, and monitor key quality metrics across the Supplier Quality Team.
Additional duties may be assigned as needed.
What are the key responsibilities?
Manage and lead all process validation activities including IQ, OQ, and PQ with existing and new suppliers.
Ensure effective and timely closure of Quality System documentation (Audit Actions, SCARs, SCNs, PANs, etc.).
Lead Quality Engineering support on project activities (Design Improvements, Supplier Transfers, Cost Improvements, New Product Introductions, etc.).
Lead Supplier Approval and Supplier Management activities 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; analyze feedback and apply problem solving and statistical techniques to improve product quality and process efficiency.
Provide leadership and mentoring within Calibration and Supplier Quality.
Establish analysis techniques and quality control tools within project activities to solve supplier quality problems.
Maintain overall responsibility for GMP standards and compliance within Aerogen's project teams and supplier engagement.
Maintain compliance with ISO and FDA Quality System regulations.
The role also supports external and internal audits and other Quality/Regulatory compliance activities as necessary.
The role requires flexibility to coordinate diverse tasks.
What education and experience are required?
BE/BS Degree.
A postgraduate qualification in Quality Assurance is preferable, but not mandatory.
At least four years of Quality Engineering experience or a related role within the medical device industry.
What key skills will make you great at the role?
Ability to work on own initiative and as a strong team member.
Proven ability to identify and drive innovative quality improvements.
Ability to work within project teams, meet deadlines, and ensure actions are addressed appropriately.
Professional quality engineering standards and strong communication skills with suppliers and colleagues at all levels.
Excellent administrative/organisational abilities with attention to detail.
Ability to liaise with suppliers, customers, and regulatory contacts in a professional 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
.
We support our global team with a range of rewards and benefits.
We offer opportunities for growth and development across the organization.
Examples of what we offer include:
Excellent medical care.
"Aerogen Connect" – our employee-led program to unite and have fun across global teams.
We pledge 1% of profits and time to charities and organizations.
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 Please include your name and preferred method of contact.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance / Supplier Quality
Industries
Medical Equipment Manufacturing
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Galway, County Galway, Ireland
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