Are you passionate about quality, product development, and ensuring that healthcare products meet the highest standards of safety and compliance?
We are looking for a Quality Engineer to join our Quality team and play a key role in supporting product development, process validation, and quality improvement activities within a highly regulated medical device environment.
In this role, you will work closely with R&D;, Manufacturing, and Quality teams, contributing to the development and maintenance of innovative medical devices while ensuring compliance with international quality and regulatory standards.
This opportunity is ideal for someone with experience in Product Development, Design Control, and Quality Assurance, who enjoys solving complex quality challenges and collaborating across functions to drive continuous improvement.
Your new role:
Partner with R&D; and Engineering teams to define product and process requirements.
Support Design Control activities throughout the product development lifecycle.
Review product verification and validation plans, protocols, and reports.
Review process validation activities to ensure compliance with quality requirements.
Participate in change impact assessments and evaluate quality implications of product or process changes.
Coordinate investigations related to verification and validation failures.
Establish and maintain product quality control plans.
Identify and lead quality improvement initiatives within manufacturing operations.
Analyze nonconforming products and support disposition decisions.
Lead root cause investigations for product and component failures identified during production or through customer complaints.




Manage CAPA activities and analyze quality trends to identify improvement opportunities.
Support suppliers and external manufacturing partners in addressing quality issues and nonconformities.
Contribute to risk assessments and product safety evaluations, including Health Hazard Assessments (HHA) when required.
How you'll make an impact:
Ensure that medical devices are developed and manufactured in compliance with regulatory and quality requirements.
Act as the Quality representative within cross-functional product development projects.
Support the successful launch and maintenance of products by identifying risks and quality concerns early in the process.
Improve manufacturing quality performance through structured problem solving and continuous improvement initiatives.
Drive investigations and corrective actions that enhance product reliability and patient safety.
Contribute to maintaining a strong Quality Culture across the organization.
About you:
Degree in Engineering, Chemistry, Biology, Physics, or another scientific discipline.
1-3 years of experience within Quality Assurance in the Medical Device or Pharmaceutical industry.
Experience supporting product design and development activities.
Good understanding of Product Development Processes and Design Control principles.
Knowledge of ISO ***** and Quality Management Systems.
Understanding of Good Manufacturing Practices (GMP).
Experience with validation activities, CAPA management, nonconformance investigations, and root cause analysis is considered a strong advantage.
Strong analytical and problem-solving skills.
Ability to work effectively in cross-functional teams.
Good communication and stakeholder management skills.
Fluent English, both written and spoken.
Proficient in Microsoft Office Suite.

📌 Quality Engineer (Mirandola)
🏢 Livanova
📍 Mirandola