Are you ready to lead a dynamic team dedicated to ensuring the highest standards of quality and regulatory compliance in a fast-paced environment? We are seeking a visionary Quality Director to provide strategic guidance and expertise across all facets of Quality and Regulatory Management. In this pivotal role, you will champion quality excellence, drive operational efficiency, and uphold compliance with industry standards, such as ISO13485 and FDA regulations.
As the Quality Director, your primary responsibilities will include:
- Providing strategic direction, leadership, and expertise in Quality and Regulatory Management.
- Contributing to the overall objectives of the company, aligning quality strategies with organizational goals.
- Developing and achieving annual operating plans for the quality function in harmony with the business Annual Operating Plan (AOP).
- Ensuring an efficient quality management system compliant with relevant quality and regulatory standards.
- Implementing metrics to enhance the effectiveness of the quality system for competitive advantage.
- Managing resources and fostering cross-functional teamwork to achieve Operational Excellence and Policy Deployment goals.
- Leading the professional development of the Quality team, supporting talent management, and enhancing skills and behaviours.
- Accountable for Management Reviews, providing objective evaluations and guidance for improvements.
- Ensuring flawless product and process launches into production and maintaining quality standards.
- Leading the supplier quality program and building strong supplier relationships.
- Educating staff on quality system regulations and their impact on their roles and responsibilities.
- Serving as the management representative for the Quality Management system.
- Ensuring compliance with safety and environmental regulations and actively participating in continuous improvement initiatives.
- Leading quality-related projects to ensure timely and budget-compliant delivery.
- Staying current with developments relevant to the company's business.
To be successful in this role, you should possess the following qualifications:
- Bachelors degree in Science, Engineering, Manufacturing, or a related field.
- Thorough knowledge of medical device quality systems (ISO13485/FDA).
- Knowledge of LEAN and Six Sigma methodologies (desirable).
- Minimum of ten years of progressive experience, with five or more years in a leadership position.
- Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA, etc.).
- Experience with SAP ERP software and proficiency in the Microsoft Office Suite.
- Strong leadership, interpersonal, and people management skills.
- Technical acumen with a "hands-on" approach.
- Exceptional communication skills at all organizational levels and with external stakeholders.
- High personal integrity and ability to maintain confidential information.
- Proven ability to innovate and drive procedural change.
- Strong analytical skills and the ability to define and solve problems.
- Initiative and leadership qualities.
- Attention to detail and ability to work with limited supervision.
If you are a results-driven, collaborative leader with a passion for quality and regulatory excellence, we invite you to consider this exciting opportunity to shape the future of our organization as a Quality Director. Join us in our commitment to delivering exceptional quality and driving innovation in the medical device industry.
For further information on this role please contact Katie Kilbane on 0861283368 / firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website https://www.hero.ie/
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