Quality & Compliance Leader, Cell Culture Manufacturing

Sartorius; Yauco (PR); Presencial; USD 90.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid vacation and sick leave

14 paid holidays annually

Medical, Dental and Vision insurance

Company Retirement Plan

On-site cafeteria

Descripción de la vacante

Sartorius is seeking a Manager of Quality to oversee the manufacturing department, ensuring compliance with FDA, ISO, and internal standards while driving continuous improvement. The role focuses on reliability of new product development, quality control, and leadership of inspectors and technicians within a regulated medical devices environment.

You will engage in production meetings, develop quality processes aligned with customer needs, and manage budgets and resources.

Formación

• Bachelor's degree in Science (Microbiology, Chemistry) or Engineering (Chemical, Mechanical).
• 5+ years' quality management experience.
• Experience in regulated environment (FDA, ISO 9001, ISO 13485).
• Proficiency with precision measuring tools, CI and quality processes including risk management.
• In depth understanding of quality control procedures and relevant legal standards.
• Strong knowledge of calibration and ability to read blue prints.
• Excellent math abilities and working knowledge of data analysis/statistical methods.
• Excellent analytical and problem solving skills.
• Leadership background.
• Experience in Medical Devices and Aseptic Filling.
• Good communication, presentation, organizational and leadership skills.

Responsabilidades

• Improve reliability of new product development processes
• Maintain company quality standards (ISO 9001 and 13485)
• Understand customer needs and requirements to develop effective quality processes
• Review products, processes and systems on an ongoing basis to determine where improvements can be made
• Oversee the product manufacturing process to ensure quality
• Supervise inspectors, technicians and other staff and provide guidance and feedback
• Participate actively in production meetings with the manufacturing team
• Submit detailed reports to appropriate executives
• Manager and develop resources and budget

Conocimientos

Quality management

FDA compliance

ISO 9001

ISO 13485

Data analysis

Risk management

Blueprint reading

Leadership

Medical devices

Aseptic filling

Communication

Educación

Bachelor's degree in Science (Microbiology, Chemistry) or Engineering (Chemical, Mechanical)

Herramientas

Calibration

Blueprint reading

Quality data tools

CI tools

Descripción del empleo

Sartorius is seeking a Manager of Quality to oversee the manufacturing department, ensuring compliance with FDA, ISO, and internal standards while driving continuous improvement. The role focuses on reliability of new product development, quality control, and leadership of inspectors and technicians within a regulated medical devices environment.

You will engage in production meetings, develop quality processes aligned with customer needs, and manage budgets and resources.