**Make a Difference in People's Lives as a Quality Engineer**
We are seeking a dedicated Quality Engineer to join our production facility in Mirandola, Italy.
In this role, you will play a key part in ensuring that our production and process control activities adhere to both our internal quality system and international medical device manufacturing regulations.
You will be part of LivaNova, a global medical technology company, worldwide leader in cardiovascular and neuromodulation solutions.
With almost 3,000 colleagues in more than 100 countries, we are facing a steady commercial growth to help create products and therapies that transform people's lives.
Duties and Responsibilities
* Nonconforming Product Handling:
o Collect and critically analyze data to take disposition decisions on nonconforming products identified in production.
o Lead proper investigations to identify the causes of components/product failures (nonconforming products from production and complaints).
o Own CAPA process and trend data to identify opportunities for CAPA.
o Support external manufacturers of semi-finished and finished products in the management of any detected non-conformities.
* Design Control & Production and Process Control:
o Establish product quality control plans.
o Review process validation planning, protocols, and reports.
o Coordinate investigations of the cause of V&V failures.
o Identify opportunities of quality improvements in the production area and lead improvement plans.
The Individual
A Master's degree in Biomedical Engineering, Physics, Chemistry, or Biology is required. Knowledge of ISO 13485 and Good Manufacturing Practices (GMP) is a plus.
A strong understanding of the sterilization process is highly preferred. Proficiency in both Italian and English is required.
Depth knowledge of Microsoft Office suite is essential.
Our Commitment to Diversity & Inclusion
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent, and free from unlawful discrimination.