Quality Engineer II
Type
Full time
Location
Job reference
Req-38581
Posted for
3 days ago
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
We recently announced plans to expand in Spain by building a new, state-of-the-art manufacturing plant in Moncada, Valencia. When it becomes operational in 2026, the plant will manufacture Edwards' surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 dedicated team members by 2029 across manufacturing, engineering, and several other professional career paths. Hiring for professional positions has started and will continue through the winter and early spring, with specialized training for manufacturing hires beginning in the fall of 2025.
The role:
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
How you will make an Impact:
Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Develop, update, and maintain technical content of risk management files
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership
What you will need:
Bachelor's Degree in Engineering or Scientific field, 2 years years experience related work experience
Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
What else we look for:
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aviso importante para las candidatos y candidatas
Requisito de vacunación COVID
Edwards se compromete a cumplir con los requisitos y orientaciones de nuestras autoridades gubernamentales y a proteger a nuestros pacientes vulnerables y a los proveedores de atención sanitaria que los tratan en todo el mundo. Como tal, todos los puestos de trabajo que interactúan con la atención sanitaria requieren la vacunación COVID-19, lo que incluye a cualquier persona que interactúe directamente con los pacientes y a aquellos que interactúan con los proveedores de atención sanitaria como parte de su función. En caso de ser contratado, como condición para el empleo, se le pedirá que presente una prueba de que se ha vacunado completamente contra la COVID-19 o que tiene una exención religiosa o médica válida para no vacunarse. Este requisito de vacunación no se aplica en los países en los que está prohibido por ley imponer la vacunación. En los países en los que las vacunas están menos disponibles, o en los que existen otros requisitos, podemos instituir medidas alternativas que optimicen la seguridad del paciente y del personal sanitario, que pueden incluir pruebas periódicas de COVID o requisitos específicos de enmascaramiento.
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