Medical Device Quality Control Technician - CAPA & NCR

Envista; Scafati; On-site; EUR 42,000 - 64,000; Full time

Job summary

Envista is seeking a Quality Assurance/Control professional to review SOPs and calibration procedures, manage DHR releases, and drive CAPA in a regulated medical device environment. The role involves NCR initiation with suppliers, cross-functional QA support, and participation in audits.

Candidates should have a Biomedical Engineering background, 1–3 years in QA/QC, and strong English proficiency for reviewing supplier documentation and standards.

Qualifications

• Bachelor’s degree in Biomedical Engineering or related technical discipline is required.
• Professional English proficiency for reviewing standards and supplier documentation.
• Experience in QA/QC within regulated environments (Medical Devices/Pharma) is required.

Responsibilities

• Review documentation for SOPs, Test Instructions and Calibration Procedures.
• Lead final review and release of Medical Device History Records (DHRs).
• Identify and initiate NCRs with suppliers.
• Own and drive CAPA to completion.
• Assist with inspections and continuous improvement initiatives.

Skills

Regulatory knowledge

Measurement tools

ERP software

Automation / AI

Attention to detail

Analytical problem solving

Cross-functional communication

Prioritization / organizational

Education

Bachelor’s degree in Biomedical Engineering

Related technical discipline

Tools

Oracle ERP

Job description

Envista is seeking a Quality Assurance/Control professional to review SOPs and calibration procedures, manage DHR releases, and drive CAPA in a regulated medical device environment. The role involves NCR initiation with suppliers, cross-functional QA support, and participation in audits.

Candidates should have a Biomedical Engineering background, 1–3 years in QA/QC, and strong English proficiency for reviewing supplier documentation and standards.