15 set - Mirandola
Livanova
Overview
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 13485, 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.
Retribuzione / Benefits
- Flexible working options
- Medical insurance
- Pension scheme
- Employee stock purchase plan
- Global recognition programme
- Additional location-based benefits
Responsabilità
- 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
Requisiti fondamentali
- 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 13485 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
- Fluent in English (written and spoken)
- Proficient in Microsoft Office Suite
- problem-solving
- cross-functional collaboration
- stakeholder management
- Design Control
- Validation activities
- CAPA management
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