Join us today and make a difference in people's lives!
We are seeking a dedicated Quality Engineer to join our production facility in Mirandola (MO).
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, and a worldwide leader in cardiovascular and neuromodulation solutions. With almost 3,000 colleagues in more than 100 countries, we are facing steady commercial growth to help create products and therapies that transform people's lives.
Duties and Responsibilities
With respect to Nonconforming product handling, you will:
Collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
Lead proper investigations to identify the causes of components/product failures (nonconforming products from production and complaints).
Own the CAPA process and trend data to identify opportunities for CAPA.
Whenever applicable, support external manufacturers of semi-finished and finished products in the management of any detected non-conformities.
With respect to Design Control & Production and Process control, you will:
Establish product quality control plans.
Review process validation planning, protocols, and reports.
Coordinate investigations of the cause of V&V failures.
Identify opportunities for quality improvements in the production area and lead improvement plans.
The Individual
Master's degree in Biomedical Engineering, Physics, Chemistry, or Biology.
Knowledge of ISO 13485 and Good Manufacturing Practices (GMP) is a plus.
Strong understanding of the sterilization process is highly preferred.
Proficiency in both Italian and English.
Depth knowledge of Microsoft Office suite.
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.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race, or any other legally protected classification.
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