Senior Engineer, Quality Assurance
Baxter International Inc.About the role
Aquí es donde salvas y sostienes vidas
En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.
Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.
Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.
Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.
Your Role at Baxter:
This is where we make life-saving products
You have deep knowledge of and experience with manufacturing processes. You understand the importance of forming relationships, establishing order, and maintaining clear communication channels. As a Sr. Quality Assurance Engineer, you are a leader who is willing to listen and inspire others by your actions. You also appreciate the stability of a large multinational company with a long history of growth and success. Your team is an extension of your family, and you know how to support them as individuals while helping them achieve results as a team.
Your role as a Senior Engineer allows you to be directly involved in the physical production that enables Baxter to fulfill our mission to save and sustain lives. You manage the line between meeting production timelines and making quality products. As a manager, you are the trusted critical connection between the business and the workers on the floor.
Your Team:
Baxter is focused on saving and sustaining lives by finding solutions to complex problems. Every single day, the manufacturing team strives to build quality products for our customers—and are sometimes met with unforeseen issues to solve. The high-caliber talent at Baxter meets these challenges head-on, as a team, to build products with the customer's needs top-of-mind. We form relationships with each other to get work done.
As a multidisciplinary environment, we are always learning from others and exchanging ideas. This means we are open to new opinions and encourage Baxter employees always to be their authentic selves and celebrate our various backgrounds.
What You'll Be Doing:
Engineer Quality Assurance is responsible for the implementation of the Charleston (Ladson) Quality System and support of the site QMR by instilling a strong quality culture that empowers the entire Charleston (Ladson) organization to identify and mitigate risk. This position is recognized as the “go to” person for product quality knowledge and guidance and will regularly interact across functions and sites to further multi-functional results.
Demonstrates high level analytical skills to identify improvement opportunities and develop workable solutions to resolve complex problems.
Assists with FDA regulatory requirements, (EN) ISO 13485, & MDSAP Certifications. Support third party Quality System Audits of Charleston Facility. Leads Non-Conforming Material process.
Track and trend key figures and quality metrics.
Assist with product quality investigations and CAPA facilitation.
Proactively investigates and delivers continuous improvement within own function and processes.
Drives process improvements and facilitates PDCA process for production.
Performs Internal Audits and Supplier Audits.
Supports Supplier Quality activity as needed (First Article Inspection, SCAR, & SNAP). Supports production floor & Manufacturing Engineer as needed (Design Transfer & PFMEA).
What You'll Bring:
Bachelor’s degree in Engineering required.
3+ years of proven experience or able to show equivalent level of knowledge in medical devices.
Strong communication and leadership abilities.
ASQ/ CQA and/or CQE desired.
Knowledge of SAP, JDE, Trackwise & Agile preferred.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. The estimated range is meant t
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