Waters Quality System Manager in Milford, Massachusetts
The Quality System Manager will be responsible for managing and developing a team of employees. This individual is responsible for leading, managing, and improving the: engineering change (ECR), data management, sales action requests to set up new part numbers, configuration management, document change, process change, corrective action & preventive Action (CAPA), internal & external audit, and management review for the Milford site. They will be responsible for leading data analysis and metrics for review by senior leadership, and driving improvement activities across the quality management system.
This role will also manage the internal and external audit process for Milford: ensuring audits are conducted on time and that non-conformances are addressed in a timely manner. This position is hands-on in a fast-paced environment which interacts with multiple functions (R&D, Engineering, Test Engineering, Reliability Engineering, Regulatory, and Purchasing) and sites (sister manufacturing sites) to resolve quality issues.
Manage a team of employees providing coaching, direction, and daily support to fulfill the responsibilities within the Quality Systems group.
Management of all the processes which are covered within Quality Systems (Global Engineering Change, Global Sales Action Requests, Document Control, Data Management, Configuration Management, Record Retention, CAPA, Internal & External Audits, Customer Questionnaires & Quality Agreements, and Improvement Projects).
Minimum of a Bachelor’s Degree in Science, Engineering, Business, Mathematics, or technical field with emphasis on statistical skills. Advanced degree preferred.
Minimum 10 years of experience in Quality Assurance or related field in a regulated industry
Minimum of 5 years of experience managing and improving Quality Systems (change management, configuration management, CAPA, internal audit, non-conforming product, etc.)
Direct experience supporting and/or leading third party audits (ISO registrars, FDA or other regulatory authorities)
Extensive Internal auditor experience
Working Experience with GMP’s
21 CFR part 820, 211, or ISO 9001 or ISO13485 preferred
Superior leadership, facilitation, and communication skills
Demonstrated implementation of continuous improvement methodologies
Working knowledge of ISO Quality Management Systems
Exposure to process and/or software validation methods
Excellent communication and interpersonal skills
Ability to work independently across multiple organizations
Good report writing and reviewing skills
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 more than 60 years. With more than 7,000 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.
Company Name: Waters Division
External Company URL: www.waters.com
Street: 34 Maple Street
Telecommute: Negotiable - Flexwise