Senior Engineer, Quality

València - Spain

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

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 16000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1500 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.

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 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.
Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
Train coach and guide lower level employees on routine procedures
Other incidental duties assigned by Leadership

What You Will Need (Required):

Bachelors Degree in Engineering or related field 4 years related industry experience or
Masters Degree or equivalent in Engineering or related field 3 years related industry experience or
Ph.D. or equivalent in Engineering or related field
Excellent written and verbal communication skills in English

What Else We Look For (Preferred):

Proven expertise in usage of MS Office Suite; CAD experience
Strong documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with lab/industrial equipment
Substantial understanding and knowledge of principles theories and concepts relevant to Engineering
Strong problem-solving organizational analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
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 inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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

Required Experience:

Senior IC

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 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.
Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
Train coach and guide lower level employees on routine procedures
Other incidental duties assigned by Leadership

What You Will Need (Required):

Bachelors Degree in Engineering or related field 4 years related industry experience or
Masters Degree or equivalent in Engineering or related field 3 years related industry experience or
Ph.D. or equivalent in Engineering or related field
Excellent written and verbal communication skills in English

What Else We Look For (Preferred):

Proven expertise in usage of MS Office Suite; CAD experience
Strong documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with lab/industrial equipment
Substantial understanding and knowledge of principles theories and concepts relevant to Engineering
Strong problem-solving organizational analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
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 inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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

Required Experience:

Senior IC

Key Skills

Quality Assurance
Six Sigma
Design Controls
FDA Regulations
ISO 9001
Minitab
Root cause Analysis
ISO 13485
Quality Systems
Quality Management
As9100
Manufacturing

Apply Now

About Company

Edwards Lifesciences

Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more

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