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Quality Manager – Cell Culture Media

Sartorius · Yauco

New
🇬🇧 English
precision measuring tools risk management calibration data analysis statistical methods ISO 9001 ISO 13485

Job description

About the role

The Manager of Quality will oversee the manufacturing department, ensuring compliance with legal standards and customer expectations while driving continual quality improvement to protect the company’s reputation and support sustainable growth.

Key responsibilities

  • Improve reliability of new product development processes.
  • Maintain company quality standards (ISO 9001 and ISO 13485).
  • Understand customer needs and develop effective quality processes.
  • Review products, processes and systems to identify improvement opportunities.
  • Oversee product manufacturing to ensure quality compliance.
  • Supervise inspectors, technicians and other staff, providing guidance and feedback.
  • Participate actively in production meetings with the manufacturing team.
  • Submit detailed reports to senior executives.
  • Manage resources and budget for the quality function.

Required profile

  • Bachelor’s degree in Science (Microbiology, Chemistry) or Engineering (Chemical, Mechanical).
  • 5+ years of quality management experience in a regulated environment (FDA, ISO 9001, ISO 13485).
  • Strong knowledge of quality control procedures and relevant legal standards.
  • Leadership experience with the ability to guide inspectors and technicians.
  • Experience in medical devices and aseptic filling processes.

Required skills

  • Proficiency with precision measuring tools.
  • Continuous improvement (CI) and risk management processes.
  • Calibration techniques and ability to read blueprints.
  • Data analysis and statistical methods.
  • Knowledge of ISO 9001 and ISO 13485 standards.

What we offer

  • Paid vacation and sick leave plus 14 paid holidays annually.
  • Impressive campus of 219,000 m² with conference areas and development center.
  • Medical, dental and vision insurance and company retirement plan.
  • On‑site cafeteria, coffee shop and occupational health offices including laboratory services.

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Published 4 days ago

Expires 1 month from now

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Sartorius

Yauco