What are the responsibilities and job description for the Director of Quality Assurance position at ACE Partners?
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 :
Salary : $160,000 - $180,000
