Overview

The Sr. Manager, QA Machining and Production, who works under the direction and supervision of the QA Director, Americas, is responsible for developing and maintaining the Operations Quality Assurance program in Waters Corporation in order to improve product and process quality within the manufacturing plant. This role will be directly responsible for the management of the Quality Management System related to manufacturing quality in the Milford, MA site.

The Manufacturing Quality function is primarily responsible for the development and management of robust quality programs that support machining and production activities. Emphasis will be on machining operations and manufacturing assembly along with OEM activities that will assure that products meet design and process specifications consistently. The role will support the inspection of machined parts and components. This role manages a team of Quality Engineers and Inspectors to support product manufacture. The Sr. Manager, QA Machining and Production, develops and monitors Quality Assurance systems to ensure that the company meets its quality objectives with regards to machining and assembly operations.

• Provide manufacturing quality leadership and vision to enable Waters success to meet company short and long-term objectives.
• Take ownership of manufacturing quality 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 manufacturing quality strategy in partnership with manufacturing operations.
• Develop and execute integration strategy for acquisitions to align manufacturing purchasing controls and mitigate any risk identified during due diligence
• Drive machined part and component inspection in the inspection area.
• Drive the resolution of quality issues with manufacturing to determine root cause, identify and implement corrective and preventive actions and verify the effectiveness of those actions
• Audit key activities for quality, regulatory compliance, and 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 production quality and customer experience
• Monitor key manufacturing metrics, understanding root cause(s) of changes in metrics, identifying trends and associated action plans
• Manage and lead a team of Quality Engineers and Inspectors through performance management
• Define and manage the budget needs to support Manufacturing Quality for sites within scope of the role.

• Bachelor's Degree in Science, Engineering or related field (Required), MBA (Preferred)
• 10+ years' experience in medical device, pharmaceutical or other manufacturing, with responsibility for a broad spectrum of Supplier Quality, Operations Quality, and/or Procurement / Purchasing elements.
• Excellent problem-solving skills, able to identify and resolve complex technical, operational and organizational problems where problems may be across disciplines.
• Proficient in influencing and persuading others internally and/or externally, including senior leaders.
• Requires broad and comprehensive understanding of Quality Systems and processes across the product lifecycle.
• 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 (both direct and indirect reports).
• Ability to manage all aspects of budget performance.