QA Specialist - Medical Devices & Compliance

Envista; Campania; On-site; EUR 45,000 - 65,000; Full time

Job summary

Kerr Italia S.r.l. in Scafati (SA) seeks a Quality Assurance Assistant to review documents, lead investigations, and manage CAPAs for medical devices in a regulated setting. The role supports inspections, data analysis, and change control, collaborating with cross-functional teams.

Requirements include a Bachelor’s degree in a scientific/technical field and 5+ years in QA roles, plus fluency in Italian and English. On-site position with growth in automation and AI-assisted processes.

Qualifications

• Bachelor’s degree in a scientific/technical discipline is required.
• Five+ years of QA, QC, or related industry experience in regulated environments.
• Experience managing nonconformances, investigations, CAPAs, and audits.

Responsibilities

• Review manufacturing and quality documentation and disposition device history records and batch records.
• Lead or support investigations of nonconformances and CAPAs through closure.
• Investigate customer complaints and assess quality data for trends.
• Support inspections, calibration, maintenance, and lab or inspection systems.
• Prepare quality metrics, risk reports, and escalation items for stakeholders.
• Create dashboards and automated workflows using Power BI, Excel, or AI-enabled tools.

Skills

Quality Assurance

Investigations & CAPA

ISO 13485

Data analysis

Italian & English

Education

Bachelor’s degree in Chemistry/Engineering/Science

Tools

Oracle/ERP systems

Quality Management Systems

Power BI / Excel dashboards

AI-enabled tools

Job description

Kerr Italia S.r.l. in Scafati (SA) seeks a Quality Assurance Assistant to review documents, lead investigations, and manage CAPAs for medical devices in a regulated setting. The role supports inspections, data analysis, and change control, collaborating with cross-functional teams.

Requirements include a Bachelor’s degree in a scientific/technical field and 5+ years in QA roles, plus fluency in Italian and English. On-site position with growth in automation and AI-assisted processes.