Quality Assurance Manager

2 weeks ago

Loch Garman, Loch Garman, Ireland Mason Alexander Full time

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.
As Quality Assurance Manager you will:
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).
What You'll Bring:
Minimum Experience:
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:
Six Sigma Green Belt
ASQ Certified Manager of Quality
ASQ Certified Quality Engineer
ASQ Certified Quality Auditor
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.
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