Join us today and make a difference in people's lives! We are looking for a Design Quality Engineer for our plant in Mirandola (MO)The Design Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality system and the international regulations governing medical device manufacturing and distribution.He/she evaluates situation of non-conforming products, collect and analyse data to propose product disposition and CAPA's to address quality issues.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.JOB FUNCTIONS:With respect to Nonconforming product handling, He/She:Collect and critically analyze data and take disposition decision on nonconforming products identified in productionLead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)Generate the evaluation of the risk posed by the observed NC on products already distributed (HHA) to determine if Stop Shipment and/or FSCA are indicated.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.Notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus the internal production process. He/She gives support to the batch record review for subassemblies/ semifinished products when neededWith respect to the Design Control & Production and Process control, He/She:Establishes product quality control plansReview design product validation planning, protocols and reportsReviews process validation planning, protocols and reportsPerform preliminary review of the change impact assessment to confirm that quality requirements are metCoordinates investigations of the cause of V&V failuresIdentify opportunities of quality improvements in the production area and lead improvement plans.REQUIREMENTS:Degree in Technical and Scientific disciplines (Physics, Chemistry, Engineering and Biology).Good knowledge of English (written and spoken);1-3 years of experience in medical device or pharmaceutical companies in QA departments. Must have: Experience on design and development product process.Depth knowledge of Microsoft Office suite;Deep knowledge of ISO13485;Good knowledge of Good Manufacturing PracticesOur 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, and check that all recruitment emails come from an @livanova.com email address.
