Quality Director - Medical Devices & Regulatory Excellence

Freudenberg; Spiddal; Sur place; EUR 110 000 - 170 000; Plein temps

Résumé du poste

Freudenberg Medical Ireland Ltd. in Spiddal, Ireland seeks a strategic Head of Quality and Regulatory Management to lead all quality systems and regulatory affairs across the site.

You will ensure ISO13485 and FDA compliance, drive continuous improvement, mentor the QA team, and partner with customers and product introductions to ensure flawless launches. You will develop annual operating plans, implement metrics, manage supplier quality, and align quality strategies with the global Freudenberg

Qualifications

• Bachelor’s degree in Science, Engineering, Manufacturing or related field.
• 10+ years of progressive experience in quality and regulatory in a medical devices environment, with 5+ years in leadership.
• In-depth knowledge of ISO13485 and FDA regulatory requirements.
• Experience using SAP ERP and proficiency in Microsoft Office Suite.
• LEAN and Six Sigma knowledge desirable.

Responsabilités

• Provide strategic direction and leadership for Quality and Regulatory Management.
• Ensure compliance with ISO13485, FDA and global requirements.
• Develop annual operating plans for the quality function aligned with the business AOP.
• Lead supplier quality program and cross-functional collaboration.
• Ensure effective QMS implementation and drive continuous improvement.

Connaissances

Strategic direction

Leadership

Quality management

Regulatory management

Cross-functional collaboration

Continuous improvement

Formation

Bachelor’s degree in Science, Engineering, Manufacturing or related field

Outils

SAP ERP

Microsoft Office

Description du poste

Freudenberg Medical Ireland Ltd. in Spiddal, Ireland seeks a strategic Head of Quality and Regulatory Management to lead all quality systems and regulatory affairs across the site.

You will ensure ISO13485 and FDA compliance, drive continuous improvement, mentor the QA team, and partner with customers and product introductions to ensure flawless launches. You will develop annual operating plans, implement metrics, manage supplier quality, and align quality strategies with the global Freudenberg