QA/RA Lead — AI-Driven Medical Device Quality & Compliance

Ketryx; Boston (MA); Hybrid; USD 130,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Generous PTO

Opportunity for professional growth

Job summary

A medical software company in Boston seeks a QA/RA Lead to oversee quality management and regulatory compliance for innovative medical device clients. The ideal candidate has 5-8 years of experience, a strong grasp of ISO 13485, and is passionate about using AI technology to enhance quality processes. This full-time role features a hybrid work schedule and competitive compensation, aiming to improve patient lives through advanced medical solutions.

Qualifications

• 5-8 years in quality systems management within medical device industry.
• Proven success in regulatory excellence.

Responsibilities

• Lead QMS setup and deployment for clients.
• Provide consulting on ISO standards.
• Scale operations for high-growth clients.

Skills

Quality Management System (QMS) management

Regulatory compliance expertise

AI technology utilization

ISO 13485 knowledge

Cybersecurity understanding

Job description

A medical software company in Boston seeks a QA/RA Lead to oversee quality management and regulatory compliance for innovative medical device clients. The ideal candidate has 5-8 years of experience, a strong grasp of ISO 13485, and is passionate about using AI technology to enhance quality processes. This full-time role features a hybrid work schedule and competitive compensation, aiming to improve patient lives through advanced medical solutions.