The Quality Engineer II plays a key role in ensuring compliance with ISO and FDA standards while supporting quality system design and validation projects at the BD Sumter site
Job Summary
The Quality Engineer II plays a key role in ensuring compliance with ISO and FDA standards while supporting quality system design and validation projects at the BD Sumter site.
This position offers opportunities for project ownership and collaboration with local, national, and international teams to drive continuous improvement and quality excellence.
BD fosters a culture of learning, growth, and innovation where employees are encouraged to bring their authentic selves and contribute to advancing global health.
Matching Summary
The Quality Engineer II plays a key role in ensuring compliance with ISO and FDA standards while supporting quality system design and validation projects at the BD Sumter site.
Skills & Requirements
Must-have
Quality system design and maintenance
Compliance with ISO and FDA guidelines
Validation protocols and process control
Use of continuous improvement tools
Statistical and investigative quality tools
Onsite collaboration and presence
Nice-to-have
Project ownership and leadership
Cross-functional team collaboration
Effective written and verbal communication
Adaptability to evolving healthcare technology
Supportive and growth-oriented culture
Key Requirements
BA/BS degree in Engineering, Sciences, or Mathematics
3 years experience in Quality Assurance/Manufacturing
Experience with Validations, IQ, OQ, PQ, DOE tools