Description

Quality Systems Specialist III

Job Summary

The Quality Systems Specialist III will play a pivotal role in maintaining and enhancing our QMS to ensure compliance with ISO 13485, FDA, EU MDR regulations, and other applicable international standards. This position will be responsible for measuring effectiveness and leading the continuous improvement of the QMS, ensuring effective corrective and preventive actions (CAPAs), and helping lead internal and external audits and regulatory inspections. The ideal candidate will have a strong background in medical device quality systems and regulatory requirements, with a proven ability to collaborate cross-functionally and present to leadership to ensure the highest level of quality assurance across the organization.

Responsibilities

QMS Management & Improvement

• Oversee the day-to-day management of the company’s Quality Management System (QMS) to ensure compliance with intern...