SENIOR DESIGN QUALITY ENGINEER

nase a nosotros hoy y cambie las cosas en la vida de las personas.
Are you a Senior Design Quality Engineer with a passion for supporting the advancement of a product portfolio whilst ensuring quality and compliance of manufacturing processes? Are you looking for a role that will provide you with the opportunity and the space to lead a talented team in seeking technical innovation and continuous improvement? If that sounds like you and you are curious to find out more about who we are and what we could offer you, please keep reading! With approximately employees worldwide and reported sales of $1.
billion in , LivaNova is a medical innovator that designs, develops and manufactures devices for cardiovascular procedures and neuromodulation.
We are a passionate and committed community, united by a desire to create meaningful products and therapies that transform the lives of patients around the world.
We do that every day by honoring our values of putting patients first, introducing meaningful innovation, acting with agility, committing to quality and integrity, working collaboratively and inclusively.
This is a great time to be part of LivaNova.
Our business is in on a growth trajectory and we have ambitious plans.
We are looking for a technical leader that can help us on this exciting journey.
Could that be you? YOUR NEW ROLE This is a role that will provide technical expertise and leadership to an established quality engineering team in our state-of-the-art manufacturing plant in Mirandola, near Bologna.
You will ensure that quality standards as well as compliance of manufacturing processes are achieved, and R&D activities are supported within dedicated projects.
Furthermore, you will contribute to continuous improvement of products and processes, ensuring that our technology makes a real difference to patients’ lives.
Your responsibilities will include.
Lead, manage, coach, and develop a team of direct reports to ensure that quality procedures are fulfilled and quality objectives are met.
Collect and critically analyse data, giving disposition decision on nonconforming products identified in production, Lead and coordinate proper investigation to identify the causes of components and/or 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 semi-finished and finished product release for the Mirandola plant disposable products With respect to the Design Control & Production and Process control, you will.
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 ABOUT YOU We are looking for an innovative and collaborative individual with a solution-focused mindset, and the ambition to leave a mark and a long-lasting legacy within our Engineering community and the wider company.
Someone interested in making a meaningful career move would fit our culture well.
We are here for long term, and we would love for you to feel the same! 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.
Solid leadership skills with the ability to engage and influence both peers and other team members, as well as coach/train on quality engineering processes, methods and activities Thorough understanding of regulatory standards –21 CFR and ISO requirements; including ISO , European Medical Device Directive /EEC, European Medical Device Regulation (EU MDR) , applicable U.
.
FDA 21 CFR requirements, and Good Manufacturing Practices (GMP); 21 CFR and ISO requirements.
Ability to work with, partner and influence cross-functionally with colleagues from R&D, Regulatory Affairs, Manufacturing, and Clinical teams.
Problem Solver.
demonstrated ability to solve problems, in an organized & structured manner.
Pragmatic and result-oriented.
capable to prioritize, plan and drive activities with specific attention to understand expectations of internal and external stakeholders Fluent in English (both written and spoken) and culturally aware - We are a truly global Quality Engineering team and you will be excited to work and collaborate with colleagues from around the world and different backgrounds Proficient in Microsoft Office Suite – including Word, Excel, PowerPoint, and Outlook WHAT WE CAN OFFER YOU In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following.
A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes, supporting your professional career growth Exposure to a State of the Art medical device development process, in close co-operation with international stakeholders Competitive base salary Variable short-term & long-term incentives Recognition.
through our STARS Program, we recognise and celebrate our colleagues’ contributions and achievements If you like the sound of the above and feel energised by the idea of making your next job a life-changer, please apply now.
We look forward to hearing from you! LivaNova valora la igualdad y celebra la diversidad.
Nos comprometemos a garantizar que nuestro proceso de selección es justo, transparente y sin discriminación ilegal.
Nuestro proceso de selección se rige por las demandas/requisitos fundamentales para el puesto, y no por prejuicios o discriminación por motivos de sexo, edad, estado civil, condición de veterano, discapacidad o dolencia no relacionada con el empleo, situación familiar, orientación sexual, religión, color, origen étnico, raza o cualquier otra clasificación protegida por la ley.
Tenga en cuenta que no aceptamos currículos no solicitados de seleccionadores o agencias de empleo.
En ausencia de un contrato de servicios de selección firmado, no consideraremos, ni aceptaremos, el pago de ninguna compensación por recomendación ni honorarios para el seleccionador.
En el caso de que un seleccionador o agencia presente un currículo o candidato sin un contrato previamente firmado, nos reservamos explícitamente el derecho de buscar y contratar a esos candidatos sin ninguna obligación económica con el seleccionador o la agencia.
¿Está buscando desarrollar una carrera importante? Tanto si trabaja en Investigación y Desarrollo, Ventas, Recursos Humanos como en otra función de apoyo, formará parte de una empresa que está transformando verdaderamente la innovación médica en soluciones significativas y, en última instancia, en una vida mejor y más sana para nuestros pacientes.
Por eso siempre estamos buscando contratar a personas apasionadas y comprometidas, con la formación técnica y la perspicacia empresarial adecuada, para cumplir nuestra misión de mejorar la vida de nuestros pacientes en todo el mundo.
Únase a LivaNova y ayúdenos a ofrecer la innovación sanitaria que importa.
Interested in learning more about working at LivaNova? Visit careers.
ivanova.
om for more.