Director of Quality, Neuro

Work Schedule: Four days on site and one remote.

Business Unit: Overseeing Neurology Portfolio

About Natus : We’re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing, and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort, Co. Galway, manufacture and distribute a range of medical device products used in the diagnosis of human neurological disorders. “The success of our company depends on our employees. This is where you come in”. If you are a strong leader with a proven track record in motivating and leading a team. A natural problem solver with strong organisational skills. Driven, and want to make an impact...this role may be for you…

Job Overview :

We have an exciting opportunity for a Director of Quality to join our team. Reporting to the Global VP of Quality, the successful candidate will be responsible for all Quality operations at the Ireland site. This is a hands-on role where we look forward to this new leader being an integral part of our team to drive success for our facility.

• 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.

Qualifications and Key Requirements:

To perform this job successfully, an individual should demonstrate the following competencies:

• Bachelor's degree in a technical discipline to include: Science, Quality or Engineering.
• Ideally have minimum 8 years of experience in a leadership role in a matrix organisations.
• Minimum of 10 years of Quality/Regulatory management in process-based manufacturing within 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.

Compensation and Benefits:

• A competitive salary package
• Comprehensive Healthcare & Life Assurance coverage
• Additional benefits such as income protection and death in service-service benefit.
  - Health & Wellbeing Events
  - Recognition Scheme
  - Free parking
  - Educational assistance

EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.