BD Biosciences and Diagnostic Solutions has merged with Waters Corporation, forming a global leader in life sciences. Our focus is on regulated, high-volume testing environments, advanced analytical technologies, and innovation in biology, chemistry, and physics.

Job Description

The role supports quality assurance and regulatory compliance throughout product development, ensuring adherence to FDA and ISO standards.

Responsibilities

• Maintain FDA and ISO regulatory requirements, focusing on product design for manufacturability, customer complaints, assembly, test, inspection, and validation throughout the development process.
• Generate process/product quality information via Critical to Quality indices and provide project teams with recommendations and solutions to emerging issues.
• Improve key quality metrics such as First Pass Acceptance, Quality Notifications, and Complaint data.
• Develop department programs an...