Biotech Quality Manager — Cell Culture & Compliance

Sartorius AG; Yauco (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid vacation and sick leave

14 paid holidays annually

Impressive campus facilities

Conference areas and developmentcenter

Medical, Dental and Vision insurance +

On-site cafeteria

On-site health offices

Job summary

Sartorius AG in Puerto Rico is seeking a Quality Manager to strengthen our FDA/ISO-compliant quality systems across product development and manufacturing. You will improve reliability of new product development, maintain ISO standards, understand customer requirements, review processes, oversee manufacturing quality, and lead inspectors and staff with guidance.

The role requires a Bachelor's in Science or Engineering, 5+ years of quality management in regulated environments, calibration and

Qualifications

• Bachelor’s degree in Science (Microbiology, Chemistry) or Engineering (Chemical, Mechanical).
• 5+ years of quality management experience.
• Experience in regulated environments (FDA, ISO 9001, ISO 13485).
• Proficiency with precision measuring tools, CI and quality processes including risk management.
• Strong understanding of quality control procedures and legal standards.
• Calibration knowledge and ability to read blueprints.
• Excellent math abilities and working knowledge of data analysis.
• Analytical and problem-solving skills.
• Leadership experience.
• Experience in Medical Devices and Aseptic Filling.
• Strong communication, presentation, and organizational 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 mgmt experience

Regulated environment

Calibration & blueprints

Data analysis

Analytical skills

Leadership experience

Communication skills

Medical devices

Aseptic filling

Education

Bachelor's degree in Science/Engineering

Tools

Precision tools

Job description

Sartorius AG in Puerto Rico is seeking a Quality Manager to strengthen our FDA/ISO-compliant quality systems across product development and manufacturing. You will improve reliability of new product development, maintain ISO standards, understand customer requirements, review processes, oversee manufacturing quality, and lead inspectors and staff with guidance.

The role requires a Bachelor's in Science or Engineering, 5+ years of quality management in regulated environments, calibration and