QA Lead – Medical Devices & Compliance

Envista Holdings Corporation; Scafati; On-site; EUR 45,000 - 65,000; Full time

Job summary

Kerr, part of Envista, is seeking a Quality Assurance professional in Italy to review device history records and drive investigations of nonconformances. You will provide oversight of calibration, validate documentation, and support regulatory reporting.

The role requires a bachelor’s degree in a relevant science/engineering field and 5+ years in regulated manufacturing environments, with fluency in Italian and English. Strong data analytics and cross-functional collaboration are essential.

Qualifications

• Five or more years of Quality Assurance, Quality Control, Manufacturing Quality, or laboratory quality experience in regulated environments.
• Experience independently managing nonconformances, investigations, CAPAs, complaints, document review, product release, or audit support.
• Working knowledge of ISO 13485 and EU Regulation 2017/745; familiarity with ISO 14971 and data integrity.

Responsibilities

• Review and disposition of Device History Records and batch records before product release.
• Lead or support investigations of nonconformances and CAPAs with root-cause analysis.
• Investigate customer complaints and analyze quality data for recurring failure modes.
• Support inspection activities and evaluation of materials, components, and finished products.
• Interpret lab results and oversee calibration and maintenance of inspection systems.
• Revise SOPs and support change-control activities and ECR/ECO processes.
• Participate in internal audits and regulatory inspections; prepare evidence and responses.
• Create quality dashboards and automated workflows using Power BI, Power Automate, Copilot, and Excel.
• Use AI-enabled tools for quality-record categorization and trend analysis with governance.

Skills

Analytical thinking

Attention to detail

Clear communication

Cross-functional collaboration

Problem solving

Italian language

English language

Education

Bachelor’s degree in Chemistry/ Chemical Engineering/ Biomedical Engineering/ Materials Science/ Biotechnology/ Industrial Engineering

Tools

Oracle ERP

Power BI

Power Automate

Copilot

Advanced Excel

Job description

Kerr, part of Envista, is seeking a Quality Assurance professional in Italy to review device history records and drive investigations of nonconformances. You will provide oversight of calibration, validate documentation, and support regulatory reporting.

The role requires a bachelor’s degree in a relevant science/engineering field and 5+ years in regulated manufacturing environments, with fluency in Italian and English. Strong data analytics and cross-functional collaboration are essential.