We are seeking a Quality Manager with deep experience in quality operations, and strong leadership skills to join a high performing flagship manufacturing facility in Co Wexford.
Responsibilities:
- Lead, mentor, and develop a dedicated quality team, creating a strong culture of excellence, ownership, and collaboration.
- Implement, maintain, and continually improve the Quality Management System in alignment with ISO 13485, EU MDR, FDA 21 CFR Part 820, and other applicable standards.
- Drive problem-solving efforts using advanced methodologies (Root Cause Analysis, statistical analysis, capability assessments).
- Oversee internal and external audits, regulatory inspections, and CAPA processes.
- Ensure robust documentation practices and compliance with GMP and GDP.
- Partner with cross-functional teams to support production goals and product quality during New Product Introductions (NPIs).
Requirements:
- At least 8 years of experience in a manufacturing environment governed by ISO standards and/or regulatory compliance.
- Supervisory or leadership experience, with a successful record of team development and performance management.
Specialised Knowledge & Skills:
- Proficiency in Root Cause Analysis, statistical analysis, problem-solving, and capability assessments.
- In-depth knowledge of key quality standards and regulations: ISO 13485, ISO 9001, EU MDR, FDA 21 CFR Part 820, GMP, and GDP.
- Experience with auditing and quality system implementation/improvement.
- Strong advantage if you hold quality certifications such as:
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- Six Sigma Green Belt
- ASQ Certified Manager of Quality
- ASQ Certified Quality Engineer
- ASQ Certified Quality Auditor
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Why Join?
- Be part of a mission-driven company delivering world-class medical devices that improve lives.
- Join a collaborative and forward-thinking team that values integrity, innovation, and results.
- Enjoy a competitive compensation package, along with growth opportunities and continuous development support.
- Make a real impact every day in an environment where quality is more than a metric—it’s a mindset.
