About This Role
This role involves providing strategic direction and leadership in all aspects of Quality and Regulatory Management, ensuring compliance with relevant standards and contributing to the company's overall objectives. The director will ensure the effective execution of quality and regulatory organizational strategies and policies, aligning them with the wider Freudenberg Medical organization. This position suits a leader with expertise in medical device quality systems who can foster teamwork and drive continuous improvement.
Responsibilities
- Provide strategic direction, leadership, and expertise in all aspects of Quality and Regulatory Management
- Contribute to the achievement of the overall objectives of the company
- Ensure effective execution of quality and regulatory organizational strategies and policies
- Develop and achieve annual operating plans for the quality function, aligned with the business AOP
- Ensure that quality strategies are aligned with the wider Freudenberg Medical organization
- Ensure that an effective and efficient quality management system, appropriate to the activities at the company, is implemented and maintained
- Ensure compliance with all relevant quality and regulatory affairs requirements, including ISO13485, FDA, global Freudenberg Medical Quality System requirements, and other appropriate standards
- Implement appropriate metrics to ensure that the quality system is efficient, effective, and utilized in a proactive manner to deliver competitive advantage
- Deliver on all budget (AOP) targets within the scope of quality and regulatory systems
- Work effectively with others to ensure that the quality function is both supportive and independent
- Manage resources and foster cross-functional teamwork to allow for Operational Excellence targets and Policy Deployment goals to be achieved
- Ensure that the Quality team has the required capabilities and competencies
- Responsible for the professional development of the Quality team
- Support the Talent Management process to continuously improve performance and develop personnel skills and behaviors
- Accountable for Management Reviews
- Provide management with objective evaluation of overall quality and regulatory affairs performance and provide guidance for implementation of improvements
- Provide leadership to ensure the flawless launch of new products and processes into production
- Partner with customers and new product introduction teams in the development and introduction of new products and processes into manufacturing
- Ensure that all product and services delivered by the company adhere to the various quality standards expected by customers and the industry generally
- Partner with customers to proactively identify and resolve quality issues and ensure products are manufactured in compliance with agreed specifications
