Quality Engineer Ii

Edwards Lifesciences Corp; Málaga; Presencial; EUR 42.000 - 56.000; Jornada completa

Descripción de la vacante

Edwards Lifesciences Corp is seeking a Quality Engineer II to join our team in Spain. The role focuses on investigating manufacturing quality issues, performing data-driven analyses, and driving process improvements across production stages.

You will develop risk management materials and create training documents to enable seamless knowledge transfer. Preferred candidates will hold CQE credentials or equivalent, possess strong documentation and communication skills, and have experience with lab

Formación

• Bachelor's degree in Engineering or a scientific field with 2 years of experience.
• Master's degree or equivalent with internship, senior project or thesis in Engineering or a scientific field.
• CQE certification is preferred.
• Good documentation, communication and interpersonal skills including negotiation.
• Basic understanding of statistical techniques.
• Experience with lab/industrial equipment.
• Solid understanding of engineering principles and processes.
• Ability to manage priorities in a fast-paced environment.

Responsabilidades

• Investigate moderately complex manufacturing quality and compliance issues (CAPA, non-conformances, audit observations) prior to final product release.
• Analyze results, make recommendations and develop reports.
• Optimize manufacturing processes using Six Sigma and Lean methods for design for manufacturing and continuous improvement.
• Develop, update, and maintain technical risk management files.
• Create training and documentation materials for production to enable knowledge transfer.
• Train technicians, give instructions, and coordinate tasks as needed.
• Perform other incidental duties as assigned by leadership.

Educación

Bachelor's degree in Engineering or a scientific field

Master's degree or equivalent with internship, senior project or thesis in Engineering or a scientific field

CQE (Certified Quality Engineer)

Descripción del empleo

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’llbring 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:

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 moderately complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean methods) for design for manufacturing and continuous process improvement. Identify opportunities for redesign/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 transfer of knowledge for project and manufacturing processes.

Assign support tasks; give instructions to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work.

Perform other incidental duties as assigned by leadership.

What you will need (Required):

Bachelor's degree in Engineering or a scientific field and 2 years of experience.

Master's degree or equivalent, and internship, senior project or thesis experience in Engineering or a scientific field, including either industry or industry/education experience.

What else we look for (Preferred):

CQE (Certified Quality Engineer), if applicable

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 is 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 to prevent injuries to themselves and others, as well as protect the environment and prevent pollution under their span of influence/control.

Digital skills in Artificial Intelligence, Power BI and data analysis.

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