Sr Product Quality Engineer

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 your expertise helps people!

You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your Team

We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.

When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.

As a Senior Product Quality Engineer, you will have the opportunity to lead by example and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish.

What You'll Be Doing

• Investigate product quality problems, determine root cause, gather, and analyze data and implement corrective action to reduce or eliminate cause. Drive quality system improvements and ensure compliance to regulatory and procedural requirements. Participate in the improvement of the manufacturing process for existing products. Review and approve work instructions, inspection documents, Bills of Material, and drawings.

• Serve as a primary point of contact for quality related matters. Responsible for leading quality initiatives with operations to improve manufacturing processes and product quality.

• Interface with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.

• Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection.

• Support operations in trouble-shooting non-conformities to confirm part defects.

• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ). Participate in external and internal regulatory compliance inspections and assist in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.

• Lead the Health Hazard Evaluation activities for the assigned areas.

• Ensure appropriate controls are defined, implemented, and satisfactorily completed for all appropriate operations. Collect, analyze, and track key data across the Batesville manufacturing site related to entity quality and to monitor and to monitor key performance indicators by working with key partners across the corporation.

• Ensure accurate and timely processing of all Quality Records along with the company’s regulatory compliance profile per 21CFR820 regulations.

• Provide training to ensure proper implementation and use of quality tools and procedures as required.

• Enable rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.

• Review/approve nonconforming materials and associated documentation.

• Review/approve product and process change control documentation and specifications.

• Use quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g., FMEA (Fai