Quality Assurance Strategist

2 days ago


Milford, Massachusetts, United States Waters Full time
Job Overview

The Americas Quality Director will lead the quality assurance organization in the Americas, providing strategic direction and leadership to support the Waters business in achieving high levels of corporate growth, product quality, business process quality/efficiency, operational excellence, and customer satisfaction.

About the Role
  • Lead the Americas Quality Assurance organization, aligned with the Waters business strategy and collaborating effectively to support long-term goals and objectives.
  • Develop and implement a global quality strategy to ensure high internal and external customer satisfaction through delivery of quality products and services.
  • Maintain a strong, globally-consistent culture of quality across the Americas region.
  • Oversee ongoing development, implementation, and maintenance of the quality management system compliant with 21 CFR 820, ISO 9001, ISO 13485, ISO 17025, and other relevant standards.
Key Responsibilities
  • Direct responsibility for Operational Quality Assurance teams located in or reporting to various sites in the US.
  • Lead significant business-level activities, including corporation-wide initiatives, projects, and resolution of business quality issues.
  • Promote an appropriate risk-based/process approach across the organization.
  • Act as a management representative for sites with direct responsibilities as required.
Requirements
  • A Bachelor's Degree in an Engineering or scientific discipline is required; a Master's Degree is preferred.
  • A minimum of 10 years of experience in Quality Leadership roles is required.
  • Proven knowledge and experience of design and execution of quality systems compliant to ISO 9001, ISO 13485, 21 CFR 820.

The estimated salary for this role is $120,000 - $180,000 per annum, based on industry standards and market research.



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