Senior CAPA & Global Product Transfer Lead

Fresenius Medical Care; Tampa (FL); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Parental leave

Performance-based bonuses

Job summary

Fresenius Medical Care is seeking a leader to harmonize global product transfer processes across design and manufacturing. You will partner with quality, R&D, and plant teams to ensure product quality at receiving sites and drive cross-functional execution of validation, inspections, and training.

The role requires 6–8 years in quality/manufacturing/engineering in regulated environments, familiarity with FDA/ISO QSRs, and strong communication skills. Bilingual Spanish is a plus.

Qualifications

• Six to eight years of relevant experience in Quality, Manufacturing and/or Engineering in a regulated industry.
• Experience with medical devices, pharma, or automotive PPAP a plus.
• Engineering background with GMP exposure and cross-functional collaboration.

Responsibilities

• Lead the harmonization and standardization of the product transfer process across regional/global areas.
• Develop, implement, and maintain Global Product Transfer processes for design and manufacturing transfers.
• Ensure product quality at receiving sites and oversee quality plans, training, inspections, and validation.

Skills

Cross-functional collaboration

Excellent communication

GMP knowledge

Quality systems knowledge

Spanish language

Education

Bachelor's Degree

Advanced Degree desirable

Job description

Fresenius Medical Care is seeking a leader to harmonize global product transfer processes across design and manufacturing. You will partner with quality, R&D, and plant teams to ensure product quality at receiving sites and drive cross-functional execution of validation, inspections, and training.

The role requires 6–8 years in quality/manufacturing/engineering in regulated environments, familiarity with FDA/ISO QSRs, and strong communication skills. Bilingual Spanish is a plus.