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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 organisation, 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 both ISO 13485 and ISO 9001 standards. Maintain and continuously improve the global QMS framework across all business units, ensuring best practices and harmonised processes. This will encompass complete QMS, e.g. Doc Control, 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, creating 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 timely and effective resolution of quality issues.
* Support regulatory submissions and ensure QMS readiness for new product introductions and market expansions.
* Monitor and interpret global regulatory trends, ensuring proactive adjustments to quality strategies and procedures.
* Develop and report on key quality metrics, driving accountability and continuous improvement across the business.
* Manage and oversee the product complaint handling process.
* Prepare and explain monthly reports as part of the Management Review process including KPIs, objectives and global projects.
* Support the Global Supply Chain Department with the Vendor Management system and ensure quality audits are being conducted with new and current vendors.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Wellness and Fitness Services
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Galway, County Galway, Ireland 1 month ago
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