Quality Engineer II – Projects & Process Improvement

Aerogen; Shannon; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Excellent medical care

Aerogen Connect

1% of profits and time to charities

Job summary

Aerogen is seeking a Quality Manufacturing specialist to support manufacturing operations, new technologies and process development. You will partner with Operations, Engineering and cross-functional teams to solve problems, strengthen processes and uphold the highest quality and regulatory standards.

Required are a STEM qualification and at least five years of Quality Manufacturing experience in medical devices or pharma, with preference for those who have implemented and validated equipment

Qualifications

• Minimum level 8 or higher STEM Qualification.
• Five years of Quality Manufacturing experience in medical devices or pharma.
• Experience implementing and validating equipment and processes is an advantage.

Responsibilities

• Provide quality support for manufacturing processes and new technologies.
• Manage process verification, validation and change control for projects.
• Collaborate with Operations and Engineering to ensure product quality and regulatory compliance.
• Establish inspection plans, frequencies and test methods for incoming materials.
• Apply risk management to anticipate failures and improve processes.
• Support GMP standards and Aerogen’s QMS.
• Lead or support continuous improvement activities.
• Perform tasks under the Senior Quality Manager and maintain quality systems.

Skills

Technical expertise

Problem solving

Results oriented

Agile innovation

Accountability

Collaboration

Regulatory awareness

Self-management

Data analysis

Education

STEM degree or higher

Tools

Minitab

Microsoft Office

Job description

Aerogen is seeking a Quality Manufacturing specialist to support manufacturing operations, new technologies and process development. You will partner with Operations, Engineering and cross-functional teams to solve problems, strengthen processes and uphold the highest quality and regulatory standards.

Required are a STEM qualification and at least five years of Quality Manufacturing experience in medical devices or pharma, with preference for those who have implemented and validated equipment