Technician Quality Control

Envista Holdings Corporation; Scafati; On-site; EUR 32,000 - 52,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory Knowledge

Measurement Tools

ERP Software

Automation & AI

Root Cause Analysis

Education

Biomedical Engineering

Tools

Oracle ERP

Calibration Equipment

HPLC

Spectrometer

Job description

Job Description

Key Responsibility

• Review documentation for SOP, Test Instruction and Calibration Procedure.
• Final review & release of Medical Device History Records (DHRs).
• Identify and initiate NCR internal and external (Supplier).
• Own and drive CAPA to completion.
• Assist with incoming inspection, in process inspection, returns & and continuous improvement initiatives.
• Support packaging control and change.
• Perform visual, dimensional, and functional inspections on in-process components and finished product lots.
• Investigate and valuate customer complaints.
• Monitor and maintain the calibration and maintenance schedules for laboratory instruments and production measurement gauges.
• Expertise of technical instrument for chemical analysis included result interpretation.
• Initiate and support change control ECR/ECO.
• Participate in cross-functional QA meetings and provide quality support.
• Assist the Quality Assurance during internal audits and external inspections by Notified Bodies or regulatory authorities (e.g., BSI, FDA etc).
• Prepare deck for QA Operations slides, including trending and escalation.

Job Requirements

Technical Skills

• Regulatory Knowledge: Understanding of ISO 13485 (Medical Devices – Quality Management Systems) and MDR 2017/745 regulations.

• Measurement Tools & Instruments for chemical analysis laboratories: Proficiency with calipers, micrometers, optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc…

• Software Systems: Experience using ERP software (e.g., Oracle)

• Automation/AI: Experience in test Automation and AI-driven

• Problem Solving: Perform root cause investigation of issue and propose potential CA

Soft Skills

• Attention to Detail: Critical for spotting minor deviations that could impact patient safety or device performance.
• Analytical Problem Solving: Ability to evaluate technical data to resolve manufacturing anomalies.
• Cross-Functional Communication: Capability to effectively collaborate with Production, R&D, and Procurement departments regarding quality issues.
• Prioritization/Organizational: Good prioritizing, organizational, interpersonal, communication and analytical skills

Typical Requirements

• Education: Bachelor’s degree in Biomedical Engineering , Materials Science, Biotechnology, Chemistry, or a related technical discipline.
• Experience: 1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals).
• Languages: Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation.

Operating Company

Kerr