Medical Device QC Specialist & CAPA Lead

Envista Holdings Corporation; Scafati; In loco; EUR 32.000 - 52.000; Tempo pieno

Descrizione del lavoro

Kerr is seeking a Quality Assurance professional in Italy to support regulatory compliance and product quality for medical devices. The role involves reviewing SOPs, performing inspections, and driving CAPA and NCR processes to ensure patient safety.

You will collaborate with Production, R&D, and Suppliers, using ISO 13485 and MDR 2017/745 knowledge, and communicate findings in English. A 1–3 year background in a regulated QA environment is preferred.

Competenze

• Bachelor’s degree in Biomedical Engineering or related field.
• 1–3 years in QA/QC for a regulated environment (Medical Devices/Pharma).
• English proficiency for reviewing standards and supplier docs.
• Knowledge of ISO 13485 and MDR 2017/745 is required.

Mansioni

• Review SOPs, Test Instructions, and Calibration Procedures.
• Final review and release of Medical Device History Records (DHRs).
• Identify and initiate NCRs with suppliers.
• Own CAPA processes to completion.
• Support inspection, returns, and continuous improvement.
• Assist with packaging control and change.
• Perform visual, dimensional, and functional inspections.
• Prepare QA operations slides with trends and escalation.

Conoscenze

Regulatory Knowledge

Measurement Tools

ERP Software

Automation & AI

Root Cause Analysis

Formazione

Biomedical Engineering

Strumenti

Oracle ERP

Calibration Equipment

HPLC

Spectrometer

Descrizione del lavoro

Kerr is seeking a Quality Assurance professional in Italy to support regulatory compliance and product quality for medical devices. The role involves reviewing SOPs, performing inspections, and driving CAPA and NCR processes to ensure patient safety.

You will collaborate with Production, R&D, and Suppliers, using ISO 13485 and MDR 2017/745 knowledge, and communicate findings in English. A 1–3 year background in a regulated QA environment is preferred.