Manager of Quality Cell Culture Media

Sartorius; Yauco (PR); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Paid vacation and sick leave

14 paid holidays annually

Medical, Dental and Vision insurance

Company Retirement Plan

On-site cafeteria

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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

Skills

Quality management

FDA compliance

ISO 9001

ISO 13485

Data analysis

Risk management

Blueprint reading

Leadership

Medical devices

Aseptic filling

Communication

Education

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

Tools

Calibration

Blueprint reading

Quality data tools

CI tools

Job description

The Manager of Quality will be responsible for overseeing the operation of the manufacturing department and the efficacy of the overall program to make sure it has been built with compliance to legal standards and meets customer expectations. The holder of this position will also ensure continual quality improvement within the facility. The goal is to help preserve our reputation by ensuring that our products and services are capable to drive sustainable growth.

Your Responsibilities

• 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

What will convince us:

• 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

What We Offer

• Paid vacation and sick leave
• 14 paid holidays annually
• Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees.
• We offer conference areas, and a development center
• Medical, Dental and Vision insurance along with Company Retirement Plan
• On-site cafeteria and coffee shop
• On-site occupational health offices including Laboratory Services

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

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About Sartorius Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We look forward to receiving your application.