Software Validation Engineer (CSV) – Medical Devices

Katalyst Healthcares & Life Sciences; Walnut Creek (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A healthcare services company in Walnut Creek, California is seeking candidates for a role in software quality assurance within medical device development. The successful applicant will develop and maintain quality assurance processes, ensuring compliance with FDA and ISO standards. This position requires a bachelor's degree and 4-5 years of relevant experience. The ideal candidate will have strong knowledge of software validation and regulatory guidelines, as well as familiarity with tools like JIRA and JAMA. Competitive compensation is offered.

Qualifications

• 4-5 years of experience in software quality assurance, preferably in the medical device industry.
• Strong understanding of quality standards and regulatory requirements.
• Experience with tools for software development, testing, and maintenance.

Responsibilities

• Develop and maintain software quality assurance processes.
• Ensure adherence to regulatory standards and industry practices.
• Support audits and inspections by regulatory bodies.

Skills

Software quality assurance

Regulatory compliance (FDA, ISO 13485)

Non-product software validation

Computer system validation (CSV)

Education

Bachelor's degree in engineering, Science or related technical field

Tools

JIRA

JAMA

Job description

A healthcare services company in Walnut Creek, California is seeking candidates for a role in software quality assurance within medical device development. The successful applicant will develop and maintain quality assurance processes, ensuring compliance with FDA and ISO standards. This position requires a bachelor's degree and 4-5 years of relevant experience. The ideal candidate will have strong knowledge of software validation and regulatory guidelines, as well as familiarity with tools like JIRA and JAMA. Competitive compensation is offered.