What are the responsibilities and job description for the Medical Device Validation/Quality Engineer (Only on w2) position at KYYBA?
· BS degree in Engineering or Technical Field or equivalent experience.
· At least 5 years Quality Engineering experience.
· Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
· Advanced computer skills, including data analysis and report writing skills.
· Prior medical device or IVD experience preferred.
· ASQ CSQE certification desired.
· Experience working in a broader enterprise/cross-division business unit model preferred.
· Ability to work in a highly matrixed and geographically diverse business environment.
· Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
· Ability to leverage and/or engage others to accomplish projects.
· Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
· Multitasks, prioritizes and meets deadlines in timely manner.
· Strong organizational and follow-up skills, as well as attention to detail.
Ability to maintain regular and predictable attendance