Quality Engineer II

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, worldclass evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patientfocused culture to deliver lifechanging innovations to those who need them most.

We recently announced plans to expand in Spain by building a new, stateoftheart 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.

How you will make an Impact:

• Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systemsprocedures to optimize product development, internal and external device manufacturing, and device distribution.

• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, nonconformances, 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 redesigndesign 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

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  What you will need (Required):

  • Bachelors Degree in Engineering or Scientific field and 2 years experience of related work experience, OR

  • Masters Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industryeducation

  • Previous experience working with labindustrial equipment

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    What else we look for (Preferred)

    • Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

    • Basic understanding of statistical techniques

    • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

    • Solid problemsolving, 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 internalexternal 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 influencecontrol

    • What is it like to work at Edwards Lifesciences in Spain?

      As a global leader in patientfocused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

      We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer onthejob development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

      Edwards Lifesciences in Spain also offers the following benefits:

      • Competitive Compensation and Benefits package
      • Flexible working hours, remote working
      • Pension plan
      • Life Insurance
      • Medical plan
      • Meal Vouchers
      • Service Awards
      • Enhanced Leave benefits
      • Employee Stock Purchase Programme
      • Employee Assistance Programme
      • Comprehensive Wellness programme including gym membership reimbursement, fresh fruit in the office, yoga lessons, subsidized massages, mindfulness sessions, educational events, charity activities and much more.

      • Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.