Lead Software Quality Analyst

Requirements

Must have:

– I hold a Bachelor’s degree in an Engineering or Technical field, or I possess equivalent experience. – I have 5 years of experience in Software Quality Engineering. – I am knowledgeable about FDA regulations, GMP, IEEE 1012, IEC 62304, and ISO 13485. – I possess strong skills in validation, risk controls, traceability, data analysis, and reporting. – I have prior experience working with medical devices. – Preferred qualifications include ASQ CSQE certification and experience in large enterprise or cross-division environments. – I possess strong communication, organizational, and multitasking abilities. – I am adaptable and thrive in fast-paced, regulated environments. – I am eligible to work with any employers without the need for sponsorship.

Responsibilities:

• I will develop and provide training on software development and validation. – I am responsible for creating, executing, and overseeing software validation protocols. – I will collaborate with engineering teams to establish system and software requirements, along with verification and validation processes. – I will implement and manage code control, defect tracking, and risk analysis. – I will conduct audits, including Part 11, and support continuous improvement initiatives. – I ensure compliance with FDA, ISO, QMS, and other relevant regulatory standards.

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Company:

We are searching for a Senior/Lead Software Quality Engineer to join our leading healthcare client. This role involves supporting software quality activities, ensuring regulatory compliance, and fostering collaboration across teams in product development and manufacturing. The position is based at our facility in Pleasanton, CA, and is a 12-month opportunity with 100% onsite work. The pay range for this position is $55 to $57 per hour on a W2 basis. If I am interested, I will click the “Apply” button.