Senior Design Quality Engineer

LivaNova

  • Mirandola, Modena
  • Tempo indeterminato
  • Full time
  • 2 mesi fa
Join us today and make a difference in people's lives!.For its Quality Assurance department in Mirandola, Italy, LivaNova, is looking for a new innovative, ambitious talent.We are currently hiring for a Senior Design Quality Engineer (m/f/d) to expand and support the advancement of our product portfolio. Your daily tasks will be related to ensuring quality as well as compliance of manufacturing processes and sustaining R&D activities within dedicated projects. Furthermore, you will contribute to continuous improvement of products and processes, ensuring that we meet our superior mission which is “patients first”.In this position, you will report directly to the Quality Engineering Manager and you will coordinate a team of Quality EngineersDuties and Responsibilities
  • Coordinate a team of quality engineers and assure that quality procedures are fulfilled and quality objectives are met.
  • Collect and critically analyse data and give disposition decision on nonconforming products identified in production, lead and coordinate 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
  • Review and approve product specification and control plan
  • Review and approve rework procedures assuring compliance with the international standards
  • Perform the semifinished and finished product release for the Mirandola disposable products
With respect to the Design Control & Production and Process control:
  • Establish product quality control plans
  • Partner the development of FMEA, fault tree analysis, and hazard analysis.
  • Review process validation planning, protocols and reports
  • Perform preliminary review of the change impact assessment to confirm that quality requirements are met
  • Plan and review V&V protocols and reports
  • Provide inputs on use of statistical tools for data analysis, sampling plans, and process capability studies
  • Coordinate investigations of the cause of V&V failures
  • Identify opportunities of quality improvements in the production area and lead improvement plan
The Individual
  • Degree in Technical and Scientific disciplines (Physics, Chemistry, Engineering and Biology).
  • Proven experience in Quality Engineering or Quality Assurance roles, in medical device or pharmaceutical environment.
  • Fluent in English – both written and spoken
  • Proficient in Microsoft Office Suite – including Word, Excel, PowerPoint, and Outlook
  • Thorough understanding of regulatory standards –21 CFR 820.30 and ISO 13485 requirements; including ISO 13485, European Medical Device Directive 93/42/EEC, European Medical Device Regulation (EU MDR) 2017/745, applicable U.S. FDA 21 CFR requirements, and Good Manufacturing Practices (GMP); 21 CFR 820.30 and ISO 13485 requirements.
  • Cross-functional Teamwork: Ability to work with R&D, Regulatory Affairs, Manufacturing, and Clinical teams.
Valuing different backgrounds:LivaNova values equality and 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.

LivaNova