Fresenius Medical Care is the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease through innovative products and services
Job Summary
Fresenius Medical Care is the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease through innovative products and services.
The role involves supporting quality initiatives by applying established procedures to ensure compliance with FDA, cGMP, and Quality System Regulations while supporting manufacturing operations and product quality.
The company offers individual career development opportunities, a corporate culture valuing innovation and quality, collaboration with a diverse global workforce, and the stability of a successful global corporation.
Matching Summary
Fresenius Medical Care is the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease through innovative products and services.
Skills & Requirements
Must-have
Process validations (IQ, OQ, PQ)
FDA, cGMP, and QSR compliance
Quality systems and CAPA management
Statistical process control and analysis
Bilingual English/Spanish
Calibration and metrology programs
Internal and external audit participation
Nice-to-have
Six Sigma Green Belt or equivalent certification
Effective verbal and written communication
Ability to work flexible schedules
Strong analytical and problem-solving skills
Collaboration with global teams
Continuous improvement mindset
Key Requirements
Bachelor’s degree in Engineering, Science, Chemistry, Biology or related field
0–2 years experience in Quality Engineering or Process Validation
Knowledge of FDA regulations (QSR, cGMP, GLP)
U.S. visa required
Bilingual English/Spanish
Certifications such as Six Sigma Green Belt, ASQ, CQE, CQA are a plus