Quality Assurance Leader - MedTech & Regulatory Readiness

T45 Labs; Santa Clara (CA); On-site; USD 127,000 - 150,000; Full time

Job summary

VahatiCor seeks a Quality Assurance Manager to lead a team of inspectors and quality engineers in Santa Clara, ensuring QMS documentation, regulatory readiness, and continuous improvement for Class III catheter-based cardiovascular devices.

You will partner with R&D and Regulatory to ensure design controls, risk management, verification/validation, and inspection readiness meet FDA and ISO 13485 standards, with hands-on leadership across manufacturing and supplier activities.

Qualifications

• 10+ years of experience in Product Quality, Quality Engineering, a technical field, or an engineering field, including at least three years in the medical device industry.
• Five years of experience in a managerial role.
• Direct experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 compliance.
• Experience with medical device design controls, risk management, design verification and validation, process validation, and design transfer.
• Bachelor’s degree in Engineering, a technical field, or a related discipline.

Responsibilities

• Support the Quality Management System (QMS) across the organization and ensure processes are documented.
• Lead quality reviews of contract manufacturers, suppliers, and manufacturing processes.
• Partner with Regulatory Affairs to support FDA submissions and regulatory inspections.
• Coordinate CAPA activities, root cause analysis, and effectiveness verification.
• Collaborate with R&D and Manufacturing to ensure product development aligns with regulatory requirements.

Skills

Quality Management

Regulatory Knowledge

Leadership

Problem Solving

Communication

Education

Bachelor’s degree in Engineering or related field

Job description

VahatiCor seeks a Quality Assurance Manager to lead a team of inspectors and quality engineers in Santa Clara, ensuring QMS documentation, regulatory readiness, and continuous improvement for Class III catheter-based cardiovascular devices.

You will partner with R&D and Regulatory to ensure design controls, risk management, verification/validation, and inspection readiness meet FDA and ISO 13485 standards, with hands-on leadership across manufacturing and supplier activities.