Quality Engineer – MedTech, Flexible Work & Impact

LivaNova PLC; Mirandola; In loco; EUR 31.000 - 50.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Pension scheme

Employee stock purchase plan

Flexible working options

Global recognition programme

Descrizione del lavoro

LivaNova PLC in Mirandola, Italy is seeking a Quality Engineer to join the Quality team and support product development, process validation, and quality improvements in a regulated medical device environment.

Responsibilities include defining product requirements, performing Design Control activities, reviewing verification/validation plans, and leading CAPA investigations to ensure compliance and patient safety. Fluency in English and cross-functional collaboration are essential.

Competenze

• 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 13485 and Quality Management Systems.
• Understanding of Good Manufacturing Practices (GMP).
• Experience with validation activities, CAPA management, nonconformance investigations, and root cause analysis is a strong advantage.
• Strong analytical and problem-solving skills with cross-functional teamwork and good communication.
• Fluent English, both written and spoken; proficient in Microsoft Office.

Mansioni

• 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.
• Lead investigations related to verification and validation failures.
• Establish and maintain product quality control plans and CAPA programs.
• Contribute to risk assessments and product safety evaluations when needed.
• Collaborate with suppliers and external partners on quality issues.

Conoscenze

Quality Assurance

Product Development

CAPA management

Design Control

Risk Management

Cross-functional teamwork

Analytical skills

MS Office

Formazione

Engineering, Chemistry, Biology, Physics or related

Descrizione del lavoro

LivaNova PLC in Mirandola, Italy is seeking a Quality Engineer to join the Quality team and support product development, process validation, and quality improvements in a regulated medical device environment.

Responsibilities include defining product requirements, performing Design Control activities, reviewing verification/validation plans, and leading CAPA investigations to ensure compliance and patient safety. Fluency in English and cross-functional collaboration are essential.