Sydney Graul

Quality Engineer Ii @CONMED Corporation

Utica, NY, US

I play a key role in supporting the design, development, and production of safe and effective medical devices by maintaining and continuously improving a compliant Quality Management System. My work centers on ensuring alignment with ISO 13485, FDA QSR, and global regulatory expectations, with a strong focus on building quality into every stage of the product lifecycle. I apply structured risk‑management and analytical methodologies—including PFMEA, DFMEA, DOE, RCA, and Fault Tree Analysis—to proactively identify failure modes, strengthen process capability, and enhance product reliability. By combining technical rigor with a deep understanding of regulatory requirements, I help create systems and processes that safeguard patient health while enabling efficient and predictable manufacturing outcomes.In addition to system‑level quality oversight, I lead critical quality execution activities such as CAPA investigations, nonconformance management, complaint evaluation, and change control. I also manage comprehensive process validation efforts, including IQ/OQ/PQ and TMV, to ensure that manufacturing processes consistently produce devices that meet stringent safety and performance standards. Collaboration is central to my work—I partner closely with Operations, Manufacturing Engineering, and R&D to drive cross‑functional problem‑solving, embed risk‑based decision‑making, and translate data insights into measurable quality improvements. Through these efforts, I contribute to delivering high‑quality medical technologies that clinicians can trust and patients can depend on.

Colorado State University

Bachelor's degree