POSITION SUMMARY
This position requires an experienced and strategic VP of Global Quality to lead and oversee the development, implementation, and continuous improvement of our Quality Management System (QMS) in accordance with ISO 13485 and applicable global regulatory requirements. This individual will play a pivotal role in driving global quality initiatives across our organization, ensuring compliance, consistency, and operational excellence in the production and lifecycle of our products.
SUPERVISORY RESPONSIBILITIES
The Global Quality Director will supervise Regional Quality Directors and Managers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Lead the global QMS strategy, ensuring alignment with ISO 13485 and ISO 9001 standards. Maintain and continuously improve the global QMS framework across all business units, ensuring best practices and harmonized processes, including document control and FMEA.
* Serve as the primary quality authority on ISO 13485 compliance globally for internal business units and subcontract distribution.
* Manage and mentor regional QMS/QA leaders, fostering a strong quality culture through collaboration and leadership.
* Oversee internal and external audits, including Notified Body audits, supplier audits, and regulatory inspections.
* Drive corrective and preventive actions (CAPAs) and ensure their timely and effective resolution.
* Support regulatory submissions and ensure QMS readiness for new product launches and market expansions.
* Monitor and interpret global regulatory trends, making proactive adjustments to quality strategies and procedures.
* Develop and report on key quality metrics, promoting accountability and continuous improvement.
* Manage the product complaint handling process.
* Prepare and present monthly reports for the Management Review, including KPIs, objectives, and global projects.
* Support the Global Supply Chain Department with vendor management and ensure quality audits are conducted with new and existing vendors.
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