As a Quality Engineer, you will support product development, process validation, and quality improvements in a highly regulated medical device setting.
You'll collaborate with R&D;, Manufacturing, and Quality to ensure compliance with ISO *****, GMP, and other standards while driving safer, more reliable devices.
Your work will influence design control, validation activities, and defect investigations, shaping product quality across the lifecycle.
This role offers meaningful impact on patient safety and a culture of continuous improvement in a global team.
Flexible working options
Medical insurance
Employee stock purchase plan
Global recognition programme
Additional location-based benefits
Partner with R&D; and Engineering to define product and process requirements
Support Design Control throughout the product development lifecycle
Review verification/validation plans, protocols, and reports
Review process validation activities for compliance
Lead change impact assessments and quality implications of changes
Coordinate investigations for verification/validation failures
Establish and maintain product quality control plans
Lead quality improvement initiatives in manufacturing operations




Analyze nonconforming products and support disposition decisions
Lead root cause investigations for production or customer-related failures
Manage CAPA activities and analyze quality trends
Support suppliers and external manufacturers with quality issues
Contribute to risk assessments and Health Hazard Assessments when required
Degree in Engineering, Chemistry, Biology, Physics, or another scientific discipline (educational background acceptable)
1–3 years of experience in Quality Assurance in Medical Device or Pharmaceutical industry
Experience supporting product design and development activities
Strong understanding of Product Development Processes and Design Control principles
Knowledge of ISO ***** and Quality Management Systems
Understanding of GMP
Experience with validation activities, CAPA management, nonconformance investigations, and root cause analysis (strong advantage)
Strong analytical and problem-solving skills
Ability to work in cross-functional teams
Good communication and stakeholder management skills
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📌 Quality Engineer (Mirandola)
🏢 Experteer Italy
📍 Mirandola