Senior Manager, QA Machining and Production

2 weeks ago

Brisbane, Queensland, Australia Waters Corporation Full time
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.

This position is also responsible for providing leadership to quality engineers focused on improving overall manufacturing performance. It will also support new product introduction activities to optimize manufacturing for new product launches. The Sr. Manager, QA Machining and Production, will ensure that effective processes to analyze quality data appropriate for manufacturing and machining performance exist and are followed. The Sr. Manager, QA Machining and Production will also be a key resource in identifying and implementing best practices for manufacturing control process improvements, problem solving, and driving customer satisfaction.

Responsibilities
  • 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.
Qualifications
  • 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.
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.

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