Waters Director, Global Design Quality Assurance in Milford, Massachusetts

For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in over 100 countries around the world.

Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Waters Corporation is currently leading a search for a Director of Global Design Quality Assurance to join our outstanding organization. In this role, the individual will lead the Global Design Quality Assurance activities and associated responsibilities across all global sites within Waters and associated businesses. The sites include, but not limited to, Waters US, Europe and Singapore in support of Waters product portfolio including the Mass Spectrometry (MS) and Chromatography instruments (LC), our Class I/II instrumentation and systems, in-vitro diagnostics (IVD) offerings, chemistry/consumables, and scientific software. This role will also support other business segments within Waters such as biomaterials, pharmaceutical, food, medical device, environmental, clinical, and academics/government research.

This Director will lead our Global Design Quality Assurance organization while partnering with R&D, Engineering, NPI (New Product Introductions), Operations, Marketing, Global Services, Business Technology, and other organizations. This position will also act as a key partner and liaison between key functions in order to ensure the successful development and launch of new products, therapies and applications, as well as providing sustaining engineering resources, and ensuring improved products and/or associated changes are in compliance with applicable business, functional and global regulatory requirements.

This position will be responsible for the on-going development, implementation and maintenance of product design assurance and design controls including necessary meeting of global standards and guidelines. This position also implements industry’s best-in-class practices based on the product performance, design control/product development process, risk management, safety analysis, and regulatory requirements. This position will also support the generation and maintenance of the product assurance strategy, and supports the applicable product teams. This individual will establish and develop strong working relationships with all our internal and international organizations, as appropriate, and work with cross-functional teams to accomplish common goals. This individual will maintain strong, productive working relationships with customers, industry experts, and regulatory agencies as appropriate. This individual will also develop relationships as appropriate with the other organizations outside of the United States.

This Director will assist in the development of Global Quality strategy, and leads the implementation and execution of the strategy where applicable. This individual will operate to drive Quality efforts that will result in higher efficiencies and effectiveness in all we do, including meeting all company and statutory regulatory requirements.

This is a great opportunity for an individual, strong leader to help grow our business and expand our next generation of products, therapies and emerging technologies.

  • Leads and manages all MS, LC, Chemistry and other applicable Global Design Quality Assurance responsibilities including the meeting of local design quality activities and initiatives.

  • Manages Global Design Quality Assurance teams and employees and ensures all quality requirements and processes are incorporated into product development and sustaining product improvement processes.

  • Development, implementation and monitoring of policies and procedures to ensure the highest levels of product quality, design quality and customer satisfaction while maintaining regulatory compliance.

  • Leads the design quality assurance initiatives, provides direction and leadership, and ensures that company objectives and regulatory requirements are met.

  • Engages, leads and collaborates with the development and sustaining teams in deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the Quality system in accordance with, but not limited to, the requirements of ISO 13485, EU IVDD, new IVDR, and regulatory requirements including 21 CFR 820, 93/42/EEC and 98/79/EC as applicable.

  • Actively participates in the product development process and ensures best-in-class practices and scientific analyses are employed.

  • Be an active contributor and knowledgeable, contributing member and represent Design Quality on all projects.

  • Drives product risk management activities and leads mitigation assessments and implementation in compliance with ISO 14971.

  • Supports usability engineering activities in compliance with ISO 62366.

  • Works cross functionally and within Waters Global Quality to ensure activities and potential improvement work is aligned, harmonized and standardized.

  • Ensures information relating to product quality and the quality system is communicated to relevant management and staff within Waters.

  • Implementation of corrective and preventive actions to ensure compliance of the quality management system with applicable quality and regulatory standards.

  • Participates and supports audit activities, both internal and external.

  • Produces, tracks and trends quality metrics to deliver tangible improvements to the overall business.

  • Manages department budgets and meets them.

  • Leads and/or participates in other projects as assigned.

  • Minimum of a Bachelor’s degree required.

  • Advanced degree is preferred (in a life science or engineering discipline; PhD, M.S., MBA or equivalent).

  • Professional certification is strongly desired (e.g. ASQ certifications)

  • Minimum of 5 years in managing employees.

  • Minimum of 7 years of experience leading Design Quality function within a disciplined industry such as medical device, pharma, Biotechnology, life sciences or similar discipline arena.

  • Proven quality leadership in the design and execution of quality systems compliant to ISO 13485, 21 CFR 820, ISO 14971 and ISO 62366.

  • Design Quality Assurance - Has an excellent technical proficiency in the knowledge of regulatory requirements and standards which impact the design, development and manufacture of products.

  • Demonstrated capability of managing design quality assurance and product development activities and objectives to plan.

  • Experience with Class I/II/III medical devices/systems and/or in-vitro diagnostics (IVD) experience is highly desired.

  • Prior experience in a leadership role with overall responsibility for directing a Quality organization is required.

  • Able to work effectively globally.

  • S/he must have a strong understanding of design control and design quality requirements.

  • S/he will have the ability to identify and analyze complex problems and recommend actions.

  • This position will develop schedules, budgets and have a comprehensive understanding of business objectives.

  • Able to effectively manage teams and projects/programs.

  • S/he will have proven track record in a matrix environment, exceptional team building skills and demonstrated ability to direct activities from concept through to completion.

  • Outstanding Work Ethic.

  • Effective communication and influencing skills.

  • High energy problem solver/achiever – Self Starter

  • Well-Organized and Detail-Oriented

  • Strong team orientation and team builder

  • Ability to mentor and development members of the team

  • Successful History of Achievement

  • Experienced International Business traveler

  • Business financial analytics experience

  • Strong analytical and problem solving skills.

  • Demonstrate sound judgment/rationale.

  • Good report writing and reviewing skills.

  • Ability to prioritize the workload and effective time management in a fast paced environment.

Quality Engineering, Design Quality, Director, Design Quality Engineering, Design Assurance, Design Control, Risk Management, R&D,

Company Name: Waters Division