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Job Details

Quality Engineer II

Type

Full time

Location
Spain - Moncada - Valencia
Job reference

Req-38581

Posted for

2 days ago

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.

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 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 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.

The role:

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.

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 to optimize moderately complex 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

  • 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.

  • Other incidental duties assigned by Leadership


What you will need:

  • Bachelor's Degree in Engineering or Scientific field, 2 years years experience related work experience

  • Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for:

  • 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 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 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

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Job reference

Req-38581

Apply Now
Type

Full time

Location
Spain - Moncada - Valencia
Posted for

2 days ago


SHARE THIS JOB
Apply Now
About Edwards Lifesciences

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.


Important Notices for Candidates

COVID Vaccination Requirement Notice

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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