Director of Quality
Natus Medical
- Gort, Co Galway
- Permanent
- Full-time
- In this role, the Director of Quality, will lead and develop a dynamic Medical Device QA team focused on standardising and deploying best in class quality processes and communications across the Ireland team.
- The role provides exemplary leadership, management, and direction to deliver on quality strategies and key performance indicators including safety, quality, on-time delivery, and efficiency targets.
- As a member of the local management Team, the Director of Quality will direct and oversee the Quality Assurance, Quality Engineering and Quality Systems while building and maintaining successful relationships with functional stakeholders.
- The role will lead the engagement and interaction with key internal customers specifically Design, Operations, Engineering and Continuous Improvement teams and will be first point of contact for key strategic external customers.
- Leadership capacity to effectively engage with local and global leaders to deliver on global solutions and innovation is a key component of this role. The role will drive engagement across multiple sites in the business to support common customer programs and medical device platform alignment.
- Provides quality system compliance with major Regulatory Authorities (U.S. FDA, Health Canada, Australian TGA, Brazilian ANVISA, Japan MHLW and PMDA, and the European Union). Delivers thought leadership on current medical device regulations and identifies industry best practices. Promote education and awareness of the above throughout the organization through regular training/briefing sessions. Integrate with corporate requirements and promote synergy/consistency with other manufacturing sites.
- Bachelor's degree in a technical discipline to include: Science, Quality or Engineering.
- Master's degree a plus.
- Ideally have minimum 8 years of experience in a leadership role in a matrix organisation.
- Minimum of 10 years of Quality/Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
- Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven.
- Ability to interface with and effectively communicate with a broad range of customers and cross functional teams, as well as executive management.
- Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for medical device manufacture.
- Quality Auditor certification, preferable but not essential.
- Possess a strong quality & compliance background and the ability to communicate effectively in a cross-functional team environment.
- Attractive salary package
- Bonus scheme
- Defined Contribution pension plan.
- Full Healthcare & Life Assurance cover
- Additional benefits also include income protection and death in service benefit
- Excellent career progression opportunities.
- Educational assistance.
- Free onsite parking.
- Active Sports and Social club.