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Quality Engineer Ii
hace 3 semanas
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.
**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 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 (required)**:
- Bachelor's Degree in Engineering or Scientific field and 2 years experience of related work experience, OR
- Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
- Previous experience working with lab/industrial equipment
**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 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
**What is it like to work at Edwards Lifesciences in Spain?**
As a global leader in patient-focused 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 on-the-job 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 reimbursemen
