Technician Quality Control

Kerr Dental; Scafati; On-site; EUR 42,000 - 52,000; Full time

Job summary

Kerr Dental is seeking a Quality Assurance professional to review SOPs, test instructions and calibration procedures, and to finalize DHRs for medical devices in a regulated environment.

The role includes driving CAPAs, handling NCRs with suppliers, supporting inspections, and contributing to continuous improvement across packaging and change control processes.

Qualifications

• Education: Bachelor's in Biomedical/Materials/Chemistry or related field.
• Experience: 1–3 years in QA/QC in regulated environments (Medical Devices/Pharma).
• Languages: Professional English proficiency for reviewing standards and supplier docs.

Responsibilities

• Review SOPs, test instructions and calibrations.
• Final review and release of Medical Device History Records (DHRs).
• Identify and initiate NCRs with suppliers.
• Own and drive CAPA to completion.
• Assist inspections, returns and continuous improvement initiatives.
• Support packaging control and change control.

Skills

Attention to Detail

Analytical problem solving

Cross-functional communication

Prioritization & organization

Quality mindset

Education

Bachelor's degree in Biomedical Engineering or related

Tools

Calipers

Micrometers

Optical comparators

HPLC

GC

pH meter

IR/Spectrometer

Oracle ERP

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.

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