Director of Quality Assurance

$160-$180K

Onsite

We're seeking a Director of Quality Assurance to lead quality strategies, oversee compliance, and manage the Quality Management System (QMS) for Class III Cardiovascular Medical Devices. This senior role involves guiding a dedicated team, ensuring alignment with FDA and international regulations, and driving quality initiatives across the organisation.

Key Responsibilities:

• Lead quality oversight and ensure regulatory compliance (FDA, ISO 13485, EU MDR).
• Develop and manage QMS, audit processes, and supplier qualifications.
• Provide regulatory guidance for product development and submissions.
• Drive cross-functional collaboration to support R&D, manufacturing, and commercial processes.
• Manage and mentor quality team members to foster a culture of quality.

Requirements:

• 15+ years of QA leadership experience in medical devices, including Class III.
• Strong track record with regulatory submissions and compliance.
• Expertise in QMS implementation and cross-functional leadership.
• Bachelor’s degree in Life Science or Engineering field.