QA/QE Expert for AI Diagnostics Platform

Bio-AI Health Inc.; Manchester (NH); On-site; USD 90,000 - 160,000; Full time

Job summary

BioAI Health Inc. is seeking a QA/QE Expert to ensure quality and compliance as we develop AI-driven cancer diagnostics software and IVDs. You will establish and maintain the QMS, support regulatory submissions, and lead audits.

The role requires deep knowledge of ISO 13485, IEC 62304, and CAPA, with collaboration across engineers, scientists, clinicians, and partners. You will work in a startup environment, helping to shape processes, quality culture, and traceability for software and AI-based

Qualifications

• BS or MS in engineering, CS, bioinformatics, or related field.
• At least five years in healthcare with preference for IVDs.
• Minimum 3 years in software quality engineering in medical devices or IVDs.
• Deep knowledge of ISO 13485 and USA Quality System Regulations.
• Deep understanding of CAPA, complaint handling, change control and nonconformities.
• Hands-on experience with ISO 13485 and IEC 62304.
• Knowledge of risk analysis (ISO 14971) and agile development.
• Ability to translate between engineers, data scientists, clinicians and commercial teams.
• Excellent communication and collaboration, detail-oriented.

Responsibilities

• Quality assurance and compliance verification for BioAI products.
• Establishing and maintaining the QMS in accordance with relevant standards.
• Maintain and pursue applicable certifications.
• Tightly work with product teams to ensure compliant design, development, manufacturing, deployment, and maintenance.
• Ensure development processes comply with regulatory and quality standards.
• Execute internal and supplier audits; host external audits.
• Execute on design control deliverables and interpret quality requirements for software development.
• Support an agile SW and AI/ML quality culture; design and maintain traceability processes.

Skills

Quality Assurance

QA/QE

Regulatory Compliance

ISO 13485

IEC 62304

CAPA Process

Audit Experience

Software Quality

Risk Management

Traceability

Agile / SDLC

Cross-functional

Education

B.S. or M.S. in engineering / CS / bioinformatics / related field

Job description

BioAI Health Inc. is seeking a QA/QE Expert to ensure quality and compliance as we develop AI-driven cancer diagnostics software and IVDs. You will establish and maintain the QMS, support regulatory submissions, and lead audits.

The role requires deep knowledge of ISO 13485, IEC 62304, and CAPA, with collaboration across engineers, scientists, clinicians, and partners. You will work in a startup environment, helping to shape processes, quality culture, and traceability for software and AI-based