Manager, Quality Inspection

Overview

The Manager, QA Inspection, who works under the direction and supervision of the QA Director, Americas, is responsible for developing and maintaining the Operations Quality Assurance inspection program in Waters Milford. This role is directly responsible for the management of the Quality Management System related to incoming and machine shop inspection in the Milford, MA site.

Operations Quality Assurance is primarily responsible for the development and management of robust quality programs that support manufacturing operations including all machining and production activities. Emphasis will be on implementing and managing effective processes for the inspection of incoming parts and parts produced by the Milford machine shop. This role manages a team of inspectors to support product manufacture. This role develops and monitors Quality Assurance systems to ensure that the company meets its quality objectives with regards to machining and assembly operations.

Responsibilities

Responsibilities:• Provide quality inspection leadership and vision to enable Waters success to meet company short and long-term objectives.• Take ownership of quality inspection throughout the product life cycle, from initial design transfer through industrialization phases as well as product launch and ongoing business management.• Develop, execute and enhance the quality inspection strategy in partnership with manufacturing operations.• Drive machined part and component inspection in the inspection area. • Support the resolution of quality issues identified in inspection to determine root cause, identify and implement corrective and preventive actions and verify the effectiveness of those actions.• Audit key activities in quality inspection to ensure regulatory compliance and identify productivity improvement opportunities• Develop strong manufacturing partnerships in alignment with the global manufacturing strategy.• Define and analyze all levels of quality data and extract useful statistics and insights about failures in order to drive meaningful improvements to quality inspection and customer experience• Monitor key inspection metrics, identify root causes of changes in metrics, identifying trends in performance and establish action plans to address.• Manage and lead a team of inspectors through appropriate performance management.• Define and manage the budget needs to support quality inspection in Milford, MA.

Qualifications

Qualifications:• Bachelor's Degree in Science, Engineering or a related field (Required).• 5+ years' experience in medical device, pharmaceutical or other manufacturing, with responsibility for leadership in a quality function.• 2+ years of people leadership experience within a quality function.• Excellent problem-solving skills to identify and resolve complex problems that may be across disciplines.• Proficient in influencing and persuading others internally and/or externally, including senior leaders.• Understanding of Waters Quality Systems and processes related to quality inspection.• Working knowledge of FDA, cGMP, Medical Device Directives, and the ISO 13485 and IVD standards.• Strong technical writer of procedures and policies.• Working knowledge of statistical sampling, audit techniques, test method validation, and Supplier Part Qualification Processes.• Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members.• Ability to manage budget performance.

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.