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Medical Device Validation/Quality Engineer (Only on w2)

KYYBA
Pleasanton, CA Full Time
POSTED ON 10/22/2025
AVAILABLE BEFORE 12/22/2025

·        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

Salary.com Estimation for Medical Device Validation/Quality Engineer (Only on w2) in Pleasanton, CA
$107,260 to $128,253
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