Quality Engineer II
Type
Full time
Location
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
Avviso importante per i candidati
Obbligo di vaccinazione contro il COVID
Edwards si impegna a rispettare i requisiti e le indicazioni delle pubbliche autorità, oltre a proteggere sia i nostri pazienti vulnerabili, sia gli operatori sanitari che se ne prendono cura in tutto il mondo. Proprio per questo richiediamo la vaccinazione contro il COVID-19 per tutte le posizioni che prevedono un’interazione con il sistema sanitario, ovvero per tutte le persone che nello svolgimento della loro mansione si interfacciano direttamente con i pazienti e quelle che interagiscono con gli operatori sanitari. L’assunzione è subordinata alla presentazione di una prova di vaccinazione completa contro il COVID-19 o di un esonero dalla vaccinazione per motivazioni mediche o religiose legittime. L’obbligo di vaccinazione non si applica nei Paesi in cui la legge vieta di imporre la vaccinazione. Nei Paesi con problemi di disponibilità dei vaccini, o che impongono altri requisiti, possiamo adottare misure alternative che ottimizzano la sicurezza dei pazienti e degli operatori sanitari, come test regolari per il COVID o requisiti specifici in materia di mascherine.
Attenzione a possibili annunci truffa
Leggi il nostro avviso sulle potenziali truffe relative al recruiting.