Senior QA Specialist - Medical Devices & Data-Driven Quality

Envista; Scafati; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Envista in Scafati, Campania, seeks a Quality Assurance professional to review manufacturing and quality records, manage nonconformances, CAPAs, and support regulatory reporting in a regulated medical devices environment. ISO 13485 and EU MDR knowledge preferred.

You will build quality dashboards, automate workflows with Power BI and Excel, apply AI-enabled tools for data-driven investigations, and ensure data integrity, traceability, and cross-functional collaboration across the organization.

Qualifikationen

• Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Biotechnology, Industrial Engineering, or a related discipline.
• Five or more years of Quality Assurance/Quality Control in regulated manufacturing.
• Experience managing nonconformances, investigations, CAPAs, and audits.
• Experience with ISO 13485 and EU 2017/745; familiarity with ISO 14971, Good Documentation Practices.
• Experience with ERP or electronic quality-management systems; Oracle is a plus.
• Fluent Italian and professional English.

Aufgaben

• Review manufacturing and quality documentation and perform final disposition of records before product release.
• Lead or support investigations of nonconformances; apply root-cause analysis; own CAPAs through closure.
• Investigate customer complaints, evaluate returns and quality data, identify recurring failure modes.
• Support inspections, calibration, maintenance, and laboratory evaluations.
• Review and revise SOPs, work instructions, and change-control activities.
• Participate in internal audits and regulatory inspections; preparation and follow-up.

Kenntnisse

Quality Assurance

Root cause analysis

Investigations

Documentation review

Data analysis

Audits

Italian language

English proficiency

Ausbildung

Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Biotechnology, Industrial Engineering, or related field

Tools

ERP systems

Oracle

Quality Management Systems

Jobbeschreibung

Envista in Scafati, Campania, seeks a Quality Assurance professional to review manufacturing and quality records, manage nonconformances, CAPAs, and support regulatory reporting in a regulated medical devices environment. ISO 13485 and EU MDR knowledge preferred.

You will build quality dashboards, automate workflows with Power BI and Excel, apply AI-enabled tools for data-driven investigations, and ensure data integrity, traceability, and cross-functional collaboration across the organization.