Join to apply for the
Supplier Quality Engineer II
role at
Aerogen
Headquartered in Galway, Ireland, with offices around the world, Aerogen is a world leader in acute care aerosol drug delivery.
We are recognised through MedTech awards and have received the Zenith award for Respiratory Care Excellence in North America.
Our employees contribute to patients' lives daily, reaching 20 million patients in over 80 countries.
Our team collaborates to innovate, challenge and test every facet of how we work.
We lead the way in finding innovative solutions to complex problems, always with the aim of delivering better patient care.
Our culture is built around We Care and we support 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 II works with external suppliers and cross-functional teams 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 to meet Aerogen Supplier Approval Requirements.
Collaborate with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts.
Champion continuous process improvement and use problem solving and statistical techniques to improve quality and efficiency.
Provide leadership and mentoring within Calibration and Supplier Quality.
Establish analysis techniques and quality control tools for project activities to solve supplier quality problems.
Maintain overall responsibility for GMP standards and compliance within project teams and supplier engagement.
Maintain compliance with ISO and FDA Quality System regulations.
The role also supports external and internal audits and related Quality/Regulatory compliance activities.
Flexibility is required to coordinate a variety of 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.
Ability to identify and drive implementation of innovative quality improvements.
Experience working within project teams, meeting deadlines and tracking actions.
Demonstrated commitment to professional quality engineering standards.
Good communication skills across all levels of the company and with suppliers.
Strong administrative/organizational abilities with 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 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 financial and non-financial rewards and benefits.
Here is a snapshot of what we offer:
Excellent medical care.
Aerogen Connect – our employee-led programme to unite and engage global teams.
Charitable initiatives, including pledging 1% of profits and time to charities and organisations.
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 with your name and preferred method of contact.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality/Regulatory
Industries
Medical Equipment Manufacturing
For more information on other roles or to set job alerts, visit our careers page.
Location: Galway, Ireland
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