This position is responsible for the day to day management of Quality and Regulatory Affairs activities. It is a remote telecommute position with 30+% travel. The role provides strategic regulatory support for all operations and operational support for the implementation of systems and procedures used to support quality and compliance standards, import/export, registrations, notifications, certifications, and maintenance throughout the whole specimen life-cycle.
The role will establish strong relationships within regional and local business partners on a cross-functional basis including Research & Development, Marketing, Legal, Consumer Affairs, and Supply Chain to ensure alignment and synchronization between Regulatory & Quality strategies and Business goals.
The Quality and Regulatory Affairs Manager will drive the strategic and operational performance of the Quality department. This position ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost and delivery, while facilitating continuous improvement and achieving commercial success. Applies Lean Manufacturing methods and applies statistical process control techniques to improve the statistical process capability. The Manager will develop, lead, and manage the quality team and ensure the efficient and effective day to day running of the department. The Quality Manager must be a change agent and possess hands-on management skills.
KEY DUTIES AND RESPONSIBILITIES