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Quality Engineer Full-time Job

1 mese fa Engineering Mirandola
Dettagli del lavoro

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, 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 creating products and therapies that transform people lives. Duties and Responsibilities With respect to Nonconforming product handling, you will:

  • Collect and critically analyse data and take disposition decision on nonconforming products identified in production
  • Lead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)
  • Own 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 the Design Control & Production and Process control, you will:

  • Establishes product quality control plans
  • Review process validation planning, protocols and reports
  • Coordinates investigations of the cause of V&V failures
  • Identify opportunities of quality improvements in the production area and lead improvement plan

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. Notice to third party agencies: Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.