Director, Quality and Regulatory

Your challenges Sets and drives the strategic vision for the organizational quality and directly oversee the site responsibilities of monitoring and improving customer experience measurements, reducing total cost of quality, ensuring regulatory compliance in our processes, and continually improving the effectiveness of the Eppendorf Quality Management System. Develop and execute multi-year quality improvement plans for the Enfield’s journey from Quality Control to Quality Assurance to Process Excellence. Partner with Engineering, Manufacturing and Supply Chain to design Quality into new products and processes. Facilitate new product introductions, process improvements, and problem resolution that leads to increased yields, efficiencies and reduction in scrap and returns. Collaborate cross functionally with, Product Management, Engineering, Procurement, and Manufacturing to ensure seamless integration of quality processes in the design phases and throughout the product life cycle. Be the site liaison between Corporate and other global site Quality leaders. Interact regularly to ensure synergies exist and flourish. Possess the tenacity to push back against and find successful resolution for policies and procedures that are burdensome to the Enfield location. Contribute and influence the senior leadership level of the Eppendorf’s organization beyond quality. Ensure that the site maintains all relevant certifications, including ISO 13485/9001 and cGMP compliance. Develop, train, and maintain Internal Audit activities. Deliver weekly, monthly, quarterly, and annual management reports as appropriate or required. Perform critical reviews of Change Request on the Quality System and Regulatory requirements. Champion, train, and support continuous improvement and problem-solving fundamental programs including but not limited to Step (System Transformation Eppendorf program), Six Sigma, Shingo, etc. to drive the best-in-class quality and process efficiencies. Lead by example to drive formal root cause problem solving as a cultural mindset and not just a tool. Lead Kaizen events as needed. Leads, coaches, and mentors Quality department personnel to include organizational and personal development, succession planning, interviewing, and any required employee discipline. Create, coordinate, and analyze input from disparate sources (manufacturing, repair, field service and installation, technical support call center, and customers) to identify and prioritize potential issues and address them before they become significant. Drive and monitor Quality System effectiveness to ensure quality goals are met. Consolidate, analyze, and report on quality metrics to identify areas for improvement. Drive both pro and reactive responses through root cause problem solving on a continuous basis. Report on lessons learned and support error-proofing initiatives. Support Procurement and Supply Chain teams to collaborate and develop our suppliers. Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. Other tasks and responsibilities as determined by management. Your expertise A bachelor's degree in engineering, Science or Business Administration. In lieu of a degree, consideration will be given to the candidate that has at least 10-15 years of proven progressive Quality Management experience leading and working in a medium to large global manufacturing facility. An MBA or MS degree is preferred. Minimum of 5 – 10 years’ experience leading and working in Quality leadership role, preferably in a manufacturing company with a global footprint. Possess a Blackbelt or equivalent certification in Lean Six Sigma or similar Quality and Process Improvement systems Must possess the ability to formulate strong and practical short and long term strategies. Strong leadership skills. Demonstrate and train the path and then let others take over to successfully execute. A genuine belief in Continuous Improvement and Operational Excellence. Lead by example to be a positive force in driving a CI mindset throughout the organization. A person that people want to listen to and follow. A sharp eye for identifying weak points in processes and organizational structures while delivering practical solutions. A strategic and analytical mindset. Strong statistical analysis capabilities. An exceptional communicator that can capture the attention and positively influence all employees and personality types, at all levels of the organization. Exquisite problem-solving capabilities. Fully understands when to use the right tools for the problem being addressed. Ability to lead organizational change Has the ability to work autonomously Your benefits at Eppendorf Competitive total rewards package including health, financial, and education benefits Innovative and Collaborative corporate culture Contribute to improving the human living condition Direct impact on business Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid-, sample-, and cell handling in laboratories worldwide. Eppendorf products are used in academic and commercial research laboratories, e.g., in companies from the pharmaceutical and biotechnological as well as the chemical and food industries. Working at Eppendorf means being part of a community of more than 5,000 scientists, engineers as well as specialists from many other disciplines across more than 30 countries. All of us are committed to one mission: Being the expert partner and advisor of choice for life sciences laboratories around the world - with our premium products, our services, and our reliability.