Director, Quality & QMS — FDA/ISO Lead

Visby Medical, Inc.; San Jose (CA); On-site; USD 200,000 - 230,000; Full time

Benefits offered by this job

Health insurance

HSA option

Paid time off

Holidays

Job summary

Visby Medical, Inc. is seeking a Director of Quality to lead the quality organization and own a lean, scalable QMS for an early-stage diagnostics company.

You will oversee a team of quality engineers, software quality engineers, and document control specialists, and serve as Visby's QMS representative with FDA and auditors. The role emphasizes risk-based quality improvements and cross-functional collaboration.

Qualifications

• Bachelor’s degree in engineering, life science or related field.
• 10+ years in medical device or IVD quality.
• 5+ years managing and developing quality teams.
• Experience hosting FDA inspections and registrar audits.
• In-depth knowledge of FDA QMSR and ISO 13485.

Responsibilities

• Lead and develop a high-performing quality team with clear goals and growth paths.
• Maintain a QMS compliant with FDA QMSR and ISO 13485 sized to Visby’s stage.
• Streamline QMS processes using risk-based approaches.
• Evaluate eQMS and digital tools to improve efficiency.
• Oversee product, supplier and software quality and compliance.

Skills

Leadership

Regulatory knowledge

Quality management

Auditing

Education

Bachelor’s degree in engineering or life sciences

Advanced degree preferred

Tools

eQMS

Job description

Visby Medical, Inc. is seeking a Director of Quality to lead the quality organization and own a lean, scalable QMS for an early-stage diagnostics company.

You will oversee a team of quality engineers, software quality engineers, and document control specialists, and serve as Visby's QMS representative with FDA and auditors. The role emphasizes risk-based quality improvements and cross-functional collaboration.