Quality Engineer I

Edwards Lifesciences Gruppe; Comunidad Valenciana; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

Edwards Lifesciences in Spain seeks a Quality Engineer to uphold regulatory standards and influence product development across the lifecycle. You will optimize manufacturing using Six Sigma and LEAN methods, lead CAPA investigations, and maintain risk management files to ensure product integrity.

You will also develop training materials for production teams and guide cross-functional projects to minimize risk.

Competenze

• Bachelor’s degree in engineering or scientific field (or Master’s in related field).
• At least 5 years of relevant work experience.
• Fluent in Spanish and English.

Mansioni

• Apply quality engineering principles to ensure regulatory compliance.
• Investigate quality issues (CAPA, non-conformances, audits) before release.
• Optimize manufacturing with Six Sigma and Lean methods.
• Develop, update and maintain risk management files.
• Develop training materials and work instructions for production.
• Coordinate technicians and assign tests, provide feedback.

Conoscenze

Quality engineering

CAPA

Six Sigma

Lean

Risk management

MS Office

CAD

Statistical techniques

Problem solving

Teamwork

Power BI

Power Automate

Formazione

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Strumenti

CAD

Power BI

Power Automate

Descrizione del lavoro

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.How You Will Make an Impact: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.Investigate 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 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.May develop, update, and maintain technical content of risk management filesDevelop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processesAssign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinates technician workOther incidental duties assigned by LeadershipWhat You Will Need (Required):Bachelor's Degree in Engineering or scientific field OR Master's Degree or equivalent in Engineering or scientific field5 years experience related work experienceFluent in Spanish & EnglishWhat Else We Look For (Preferred):Good computer skills in usage of MS Office Suite; CAD experienceDocumentation, communication and interpersonal relationship skillsUnderstanding of statistical techniquesPrevious experience working with lab/industrial equipmentGood understanding and knowledge of principles, theories, and concepts relevant to EngineeringGood problem-solving, organizational, analytical and critical thinking skillsGood understanding of processes and equipment used in assigned workKnowledge of and adherence to Quality systemsStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including immediate supervisor and other team members in the section or groupAbility to build stable working relationships internallyAdhere 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/controlDigital capabilities (Power BI, Power Automate) and AI knowledgePlease submit your application in English