Supplier Quality Engineer II

Aerogen Ltd.; Galway; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading medical device company in Galway seeks a Supplier Quality Engineer II who will manage supplier quality, lead validation processes, and ensure compliance with ISO and FDA standards. The ideal candidate has a BE/BS degree, four years of industry experience, and excellent communication skills. Join us to help transform patient lives and support innovative quality improvements.

Benefits

Excellent medical care

'Aerogen Connect' employee-led programme

Charity support commitment

Qualifications

• At least four years Quality Engineering experience within the medical device industry.
• Proven experience in managing process validation activities.

Responsibilities

• Manage and lead process validation activities with suppliers.
• Ensure timely closure of Quality System documentation.
• Lead project activities in quality engineering.

Skills

Ability to work on own initiative

Strong team collaboration

Good communication skills

High attention to detail

Understanding of ISO 13485 and FDA QSR standards

Education

BE/BS Degree

Post-graduate qualification in Quality Assurance

Job description

Join to apply for the Supplier Quality Engineer II role at Aerogen

Headquartered in Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through MedTech awards and Zenith awards for Respiratory Care Excellence, our employees make a difference to patients’ lives every day, reaching 20 million patients in over 80 countries.

Our talented and skilled team collaborates to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way with innovative solutions to complex problems, delivering better patient care. Our core culture is “We Care,” and as we grow, 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 II role 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 while driving key quality metrics across the Supplier Quality Team. Other activities 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 at Aerogen on project activities i.e.: Design Improvements, Supplier Transfers, Cost Improvements, and 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 and analyse feedback to identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
• Provide leadership and mentoring of resources within Calibration and Supplier Quality.
• Establish analysis techniques and other quality control tools within project activities and use them to solve specific supplier quality problems.
• 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 will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary. The role will require a high degree of flexibility to coordinate the variety of tasks.

What education and experience are required?

• BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
• At least four 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.
• 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 standards.

What is it like to work at Aerogen?

Our purpose is to transform patient lives and our ethos is to #discoverbetter. We offer a range of financial and non-financial rewards and benefits. Here is what we offer:

• Excellent medical care.
• ‘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.

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 [e-mail]. Please include your name and preferred method of contact.

EEO statements are followed as applicable.