Overview

Lead the Americas Quality Assurance organization, providing long-term strategic direction with the aim of supporting the Waters business in achieving the highest levels of corporate growth, product quality, business process quality/efficiency, operational excellence and customer satisfaction, while meeting regulatory needs, through ensuring that:

• The Quality Assurance organization within the Americas is aligned to the Waters business and collaborates effectively to support the achievement of Waters' long-term strategy and business goals
• The Global Quality Assurance Strategy is developed and implemented to support high levels of internal and external customer satisfaction through delivery of quality products and an effective and efficient service to the business
• A strong, globally-consistent culture of Quality is developed and maintained throughout Americas to support increasing inclusion of all Waters staff in supporting customer satisfaction
• There is ongoing development, implementation, and maintenance of the quality management system to 21 CFR 820, ISO 9001, ISO 13485, ISO17025 and ISO17034 and other relevant standards as required
• The effectiveness of the Quality organization is supported through appropriately qualified, experienced and motivated staff, an optimized organization structure and a development-focused environment

• Milford, MA (US)
• Taunton, MA (US)
• Franklin, MA (US)
• New Castle, DE (US)
• Eden Prairie, MN (US)
• Lindon, UT (US)
• Golden, CO (US)

• Lead the Americas Quality Assurance department to provide strategic direction and leadership in line with Waters/Global Quality strategy and other influences including industrial and market intelligence and any local or cultural needs
• Provide functional expertise and knowledge in the development and implementation of Global Quality strategy as applicable to Americas Quality Assurance
• Collaborate with all key stakeholders and other Quality leaders to drive alignment and consistency in goals, objectives and performance metrics in support of the Global Quality strategy
• Provide high level consultation and guidance within the supported parts of the business to ensure consistency in understanding of needs and approach
• Support the ongoing effectiveness and continual improvement of applicable Americas site Quality Management Systems
• Support and lead initiatives to harmonize elements of the Quality Management System within Americas sites as appropriate
• Ensure that relevant Regulatory/ISO compliance is maintained while ensuring the business is supported effectively
• Collaborate with key stakeholders to ensure the Quality of new and existing products is maximized and successfully maintained
• Lead significant, business level activities including corporation-wide or multi-site initiatives, projects and resolution of business quality issues as required
• Support all Business Development activities undertaken by the Corporate Development group. This includes developing processes, conducting due diligence activities against Waters requirements of all business mergers & acquisition targets, and leading the integration of newly acquired companies into the Waters QMS to ensure smooth operating transition
• Proactively identify and drive corporation-wide or multi-site improvements that will enhance the performance of the Waters business
• Collaborate with all key stakeholders and other Quality leaders to drive Quality culture within the Waters business
• Promote an appropriate risk based/process approach across the organization
• Act as a management representative for sites with direct responsibilities as appropriate
• Deputize for the VP Global Quality Assurance as required
• Perform other duties as assigned.

• A Bachelor's Degree in an Engineering or scientific discipline is required, a Master's Degree is preferred.
• A minimum of 10 years of experience in Quality Leadership roles is required
• Proven knowledge and experience of design and execution of quality systems compliant to ISO 9001, ISO 13485, 21 CFR 820
• Understanding of 21 CFR part 11, ISO 14971, ISO17025 and other relevant standards