Senior Software Quality Engineer
$116,569–$116,575 year
Remote · Pleasanton, California, United States or New York City, New York, United States
Pleasanton, California, United States or New York City, New York, United StatesRemoteContract$116,569–$116,575 yearMid LevelBachelors DegreeEnterprise
Type
Contract
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise
Job Summary
As a Senior Software Quality Engineer, the candidate will execute software quality engineering methodologies while ensuring compliance with FDA, ISO 13485, and IEC 62304 standards for medical software systems. The role involves collaboration with engineering teams to support the verification and validation process and conducting risk analyses and audits.
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, or a related technical field (or equivalent experience)
- Minimum 5 years of experience in Quality Engineering within the medical device or in vitro diagnostics industry
- Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485
- Strong computer skills, including data analysis and technical report writing
- Prior experience working in a regulated environment (medical device or IVD)
- Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels
- Strong organizational and time management skills with keen attention to detail
- Ability to manage multiple priorities and meet tight deadlines in a dynamic environment
- Must maintain regular and predictable attendance
Desired Qualifications
- ASQ CSQE certification preferred
- Experience working in a cross-functional enterprise environment
- Familiarity with Six Sigma, Lean principles, or CAPA methodologies
- Experience with software traceability, validation documentation, and risk management tools
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