Regulatory Software QA Engineer - Medical Devices

Comunidade Metodista; Santa Clara (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst HealthCares and Life Sciences in Santa Clara, CA is seeking a Medical Device & Regulations Engineer to develop and maintain software QA processes for non-product software used in medical device development.

You will ensure compliance with FDA, ISO 13485, IEC 62304, support audits, validate computerized systems, and collaborate with software development and IT teams to strengthen quality practices.

Qualifications

• Bachelor's degree in engineering, science or related technical field.
• 4–5 years' experience in software quality assurance or validation in the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304.
• Experience with non-product software validation, testing tools and maintenance.
• Understanding of GxP, 21 CFR Part 11 applicability/criticality assessment.
• Experience with validation deliverables: Requirements, Plan, Protocols, Reports, Traceability Matrix.
• Familiarity with PLM and lifecycle management concepts.

Responsibilities

• Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
• Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
• Support audits and inspections by regulatory bodies, ensuring compliance of non-product software systems.
• Validate computerized systems and assess applicability/criticality of GxP and 21 CFR Part 11.
• Create and review validation deliverables including Requirements, Plan, Protocols, and Reports.

Skills

Quality assurance

Regulatory compliance

Software validation

GxP awareness

FDA 21 CFR Part 11

CSV activities

Education

Bachelor's degree in engineering or related field

Tools

JIRA

JAMA

PLM tools

Job description

Katalyst HealthCares and Life Sciences in Santa Clara, CA is seeking a Medical Device & Regulations Engineer to develop and maintain software QA processes for non-product software used in medical device development.

You will ensure compliance with FDA, ISO 13485, IEC 62304, support audits, validate computerized systems, and collaborate with software development and IT teams to strengthen quality practices.