Software Validation QA Engineer | 9/80 Schedule & ISO 13485

huMannity Medtec; Santa Clarita (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

9/80 work schedule

26 long weekends annually

Job summary

A medical technology company in Santa Clarita is seeking a Software Validation Quality Engineer to join their Quality Assurance team. This role involves ensuring software systems meet compliance standards, executing validation protocols, and supporting process improvements within a collaborative environment. Ideal candidates should possess a Bachelor's degree and experience in the medical device industry, particularly with ISO 13485 and IEC 62304 standards.

Qualifications

• 3+ years of experience in the medical device industry required.
• Experience with ISO 13485:2016 and IEC 62304 is a must.
• Knowledge of FDA’s General Principles of Software Validation Guidance needed.

Responsibilities

• Identify software that needs qualification, verification, or validation.
• Execute and maintain software quality engineering methodologies.
• Work with R&D and engineering teams to complete software verification and validation processes.

Skills

Software validation methodologies

Risk management

Technical writing

Data analysis

Education

Bachelor’s degree

Tools

Test equipment

ISO 13485 standards

Job description

A medical technology company in Santa Clarita is seeking a Software Validation Quality Engineer to join their Quality Assurance team. This role involves ensuring software systems meet compliance standards, executing validation protocols, and supporting process improvements within a collaborative environment. Ideal candidates should possess a Bachelor's degree and experience in the medical device industry, particularly with ISO 13485 and IEC 62304 standards.