Quality Engineer I

Edwards Lifesciences; Valencia; On-site; EUR 42,000 - 64,000; Full time

Job summary

Edwards Lifesciences in Valencia, Spain seeks a Quality Engineer to apply quality engineering principles across the product lifecycle, ensuring regulatory compliance and optimization of development and manufacturing processes. This role requires a degree in engineering or a scientific field and at least 5 years of related experience, with fluency in both Spanish and English.

You will investigate quality issues (CAPA, non-conformances, audits), apply Six Sigma and LEAN methods to improve

Qualifications

• Bachelor's degree (or higher) in Engineering or scientific field required.
• 5 years of related work experience.
• Fluent in Spanish and English as working languages.

Responsibilities

• Apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution.
• Investigate manufacturing quality and compliance issues (CAPA, non-conformances, audits) and provide data-driven recommendations.
• Use Six Sigma/LEAN methods to improve design for manufacturing and processes; identify redesign opportunities.
• Develop, update, and maintain risk management files and related documentation.
• Create training materials and work instructions; train technicians and coordinate tasks.

Skills

Fluent in Spanish

Fluent in English

Problem solving

Analytical thinking

Six Sigma

LEAN

Quality engineering

Documentation

Team collaboration

Education

Bachelor's Degree in Engineering or scientific field

Master's Degree in Engineering or scientific field

Tools

Power BI

Power Automate

CAD

MS Office

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