Quality Systems Manager

Description

• Work closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained.
• Leads internal and customer audits. Manages audit responses and closure internally and with customers.
• Ensure the quality policy/system is planned, understood, implemented and maintained through the interpretation of FDA regulations, corporate policy and global regulations and the implementation of an effective and compliant quality system.
• Establish, implement and maintain strong internal audit and management review/escalation process and functions to monitor, escalate and report to executive management/management representative on the suitability, effectiveness and overall performance of the quality system.
• Establish, implement and maintain processes/procedures to ensure excellence in configuration control, quality records management and training.
• Establish, implement and maintain processes/procedures for a closed-loop CAPA system to ensure quality system and product performance are monitored, trended and appropriate actions are taken in a timely manner.
• Ensure appropriate resources are available to effectively maintain the quality system (people, facilities, tools and training).
• Coordinates and leads all customer audits, manages customer communication addressing customer observations and recommendations.

• Initiate, maintain and monitor through internal audit a Quality System that provides for efficient and effective business systems and ensures compliance with domestic, international regulatory and corporate requirements.
• Assure management reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/actions.
• Implement a strong CAPA process that ensures all input sources are reviewed, trended, and the appropriate actions are taken to ensure continuous improvement in the quality system.
• Manage all aspects of internal audit, configuration assurance and quality records for the business.
• Linked with Human Resources assure training is available to all employees regarding the Quality System and the Quality Policy.
• Promote systems and encourage employee participation in the continuous improvement process and facilitate employee empowerment.

• Actively participate in the development of strategic quality improvement measures, plans and assist teams with the development of tactical measures.
• Provide the leadership necessary to ensure that strategic and annual quality planning is integrated into strategic and operating plans with broad-based organizational involvement. Implement and maintain systems to ensure the measurement of progress towards key quality goals and objectives.
• Assess and analyze the Quality System for efficient compliance to regulations on a periodic basis and provide results and recommended strategies.
• Influence all business functions to apply appropriate quality tools including Lean, Six Sigma, TQM principals, business process improvement methods and statistical methods (e.g. design of experiments, statistical process control).
• Maintains alliance with local and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.
• Support internal functional partners and ensure process owners are trained and well educated in the areas of quality system regulations as applicable to their areas.
• Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team. Must have had experience with formal goal and objectives setting