Quality Engineer I

Edwards Lifesciences S.L. [Spain]; Valencia; On-site; EUR 45,000 - 65,000; Full time

Job summary

Edwards Lifesciences Gruppe in Valencia, Spain, seeks a Quality Engineer to strengthen our quality team and ensure regulatory compliance while optimizing product development across manufacturing and distribution.

The role involves investigating product quality issues, applying Six Sigma/LEAN methods, and contributing to risk management. Fluent Spanish and English, an engineering degree, and 5 years of related experience are required.

Qualifications

• Bachelor's degree in Engineering or related field; 5 years of relevant experience.
• Master's degree or equivalent is a plus and may substitute for part of the experience.

Responsibilities

• Applies quality engineering principles to ensure regulatory compliance and optimize product development.
• Investigates manufacturing quality and compliance issues (CAPA, non-conformances, audits).
• Optimizes manufacturing through SIX Sigma and LEAN methods and guides design for manufacturing.
• Identifies opportunities for redesign of equipment, tools, fixtures to reduce risk.
• Develops and maintains risk management documentation and training materials.
• Gives work instructions to technicians, trains staff, and coordinates tasks.
• Performs other duties assigned by Leadership.

Skills

Quality engineering

Problem solving

Statistical methods

CAD experience

MS Office

Power BI

Power Automate

Bilingual EN/ES

Education

Bachelor's degree in Engineering

Master's degree or equivalent

Tools

CAD

Power BI

Power Automate

Job description

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 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 coordinates technician work
• Other incidental duties assigned by Leadership

What You Will Need (Required):

• Bachelor's Degree in Engineering or scientific field OR Master's Degree or equivalent in Engineering or scientific field 5 years experience related work experience Fluent in Spanish & English

What Else We Look For (Preferred):

• Good computer skills in usage of MS Office Suite; CAD experience Documentation, communication and interpersonal relationship skills Understanding of statistical techniques Previous experience working with lab/industrial equipment Good understanding and knowledge of principles, theories, and concepts relevant to Engineering Good problem-solving, organizational, analytical and critical thinking skills Good 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 immediate supervisor and other team members in the section or group Ability to build stable working relationships internally 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 Digital capabilities (Power BI, Power Automate) and AI knowledge

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.