QA Director, America - Waters Corporation
Milford, MA
About the Job
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
Direct responsibility for Operational Quality Assurance teams located in or reporting to:
- Milford, MA (US)
- Taunton, MA (US)
- Franklin, MA (US)
- New Castle, DE (US)
- Eden Prairie, MN (US)
- Lindon, UT (US)
- Golden, CO (US)
Responsibilities
- 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 organisation
- 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.
Qualifications
- 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
Company Description
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.