Quality Engineer II, Medical Devices & Process Optimizer

Integer Holdings Corporation; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Integer Holdings Corporation is seeking a Quality Engineer to apply advanced quality tools in a medical device manufacturing environment. You will assist with regulatory inspections, coordinate CAPA activities, and review changes across design and production documentation.

You will work with cross-functional teams to ensure device quality and regulatory compliance, while leveraging the company’s QMS and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in engineering or related field plus 3 years of relevant experience.
• Awareness of domestic and international regulations (ISO, QSR, UL, MDD, TGA).
• Proficiency with Microsoft Office tools.

Responsibilities

• Apply quality engineering methods using advanced tools to resolve problems in medical device manufacturing.
• Support regulatory inspections, audits, and investigations of quality systems and processes.
• Review changes to BOMs, assembly procedures, drawings, specifications, FMEAs, and control plans.
• Lead CAPA activities and project improvements to meet quality KPIs.
• Collaborate with cross-functional teams to ensure product and process quality from design through production.

Skills

Quality engineering

Problem solving

Communication

Team collaboration

Education

Bachelor’s degree in engineering or related field

Tools

Microsoft Office

Job description

Integer Holdings Corporation is seeking a Quality Engineer to apply advanced quality tools in a medical device manufacturing environment. You will assist with regulatory inspections, coordinate CAPA activities, and review changes across design and production documentation.

You will work with cross-functional teams to ensure device quality and regulatory compliance, while leveraging the company’s QMS and continuous improvement initiatives.