Quality Assurance Technician — Medical Device (GMP/ISO)

Dexcom Ireland - Athenry; Athenry; On-site; EUR 37,000 - 48,000; Full time

Job summary

Dexcom Ireland is seeking a Quality Technician to provide hands-on quality support within a regulated medical device manufacturing environment. The role ensures compliance with GMP and ISO standards while supporting manufacturing operations and quality documentation.

You will participate in nonconformance investigations, audits, CAPA activities, and continuous improvement to uphold product quality and regulatory readiness across the site.

Qualifications

• 2–4 years of experience in a medical device or similarly regulated manufacturing environment.
• Strong familiarity with ISO 13485, FDA 21 CFR Part 11/820, and MDSAP.
• Ability to read specifications, inspection criteria and engineering drawings.

Responsibilities

• Support Quality Engineering activities including Change Order processing and CAPA investigations.
• Collect data and perform inspections to support investigations led by Quality Engineers.
• Assist on the manufacturing floor and support the inspection team with methods and specifications.
• Ensure compliance with GMP, GLP, ISO and Six Sigma requirements.
• Maintain and update quality procedures and materials for finished products.

Skills

Quality systems

Regulatory compliance

CAPA investigations

Quality control

Education

Level 6 in Quality

Job description

Dexcom Ireland is seeking a Quality Technician to provide hands-on quality support within a regulated medical device manufacturing environment. The role ensures compliance with GMP and ISO standards while supporting manufacturing operations and quality documentation.

You will participate in nonconformance investigations, audits, CAPA activities, and continuous improvement to uphold product quality and regulatory readiness across the site.