Quality Engineer II — Remote Med Device Quality & CAPA

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

Job summary

Integer Holdings Corporation seeks a Quality Engineer to support design and manufacturing quality in the medical device sector. You will apply advanced quality tools, ensure compliance with QMS, FDA and ISO standards, and collaborate with cross-functional teams to resolve issues and drive CAPA improvements.

You will review changes, develop test methods, support inspections, and maintain device history records while upholding Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration,

Qualifications

• Bachelor's degree in engineering or related field is required.
• 3+ years of relevant experience in quality engineering or medical devices is preferred.
• Familiarity with ISO, QSR, UL, FDA regulations and QMS is essential.

Responsibilities

• Manufacturing support: assist regulatory inspections and inquiries.
• Review BOM changes, assembly procedures, and DFM/DFMEA docs.
• Lead test method protocols and validation reports.
• Support CAPA activities and non-conforming material processes.
• Collaborate across teams to ensure product quality and process improvements.

Skills

Regulatory knowledge

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office

Job description

Integer Holdings Corporation seeks a Quality Engineer to support design and manufacturing quality in the medical device sector. You will apply advanced quality tools, ensure compliance with QMS, FDA and ISO standards, and collaborate with cross-functional teams to resolve issues and drive CAPA improvements.

You will review changes, develop test methods, support inspections, and maintain device history records while upholding Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration,