Global Product Transfer & CAPA Lead (Quality)

Fresenius Medical Care; United States; Remote; USD 130,000 - 190,000; 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 Senior Global Product Transfer Leader to harmonize and standardize product transfer processes across regional/global areas, ensuring quality during transfers and compliance with FDA QSRs and ISO 13485.

You will partner with CE quality, R&D, plant quality and manufacturing teams to transfer new products or site-to-site transfers, drive continuous improvement, and support an efficient, compliant transfer program with up to 30% travel.

Qualifications

• 6–8 years of experience in Quality, Manufacturing and/or Engineering.
• Medical device, pharma or other regulated industry experience.
• GMP environment design/manufacturing experience.
• Strong cross-functional collaboration.
• Excellent communication skills.
• Bilingual in Spanish would be a plus.

Responsibilities

• Lead harmonization and standardization of the product transfer process.
• Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.
• Ensure product quality at the receiving manufacturing site level during product transfer projects.
• Ensure transfer projects comply with all quality and regulatory requirements, with defined quality planning and inspections plans.
• Partner with CE quality, R&D, plant quality and manufacturing teams in transfers between sites.
• Oversee and execute policies to ensure consistent outcomes in transfers.
• Develop and execute quality and validation plans for transfers.
• Deliver procedural updates for new products at receiving facilities.
• Ensure all transfer activities are in compliance with the quality system, FDA QSRs and ISO 13485.
• Perform other related duties as assigned.
• Travel up to 30% may be required.

Skills

Quality experience

Manufacturing experience

Engineering background

GMP experience

Medical device/pharma knowledge

FDA/MDR knowledge

Cross-functional collaboration

Spanish language (nice to have)

Education

Bachelor’s Degree

Advanced Degree desirable

Job description

Fresenius Medical Care is seeking a Senior Global Product Transfer Leader to harmonize and standardize product transfer processes across regional/global areas, ensuring quality during transfers and compliance with FDA QSRs and ISO 13485.

You will partner with CE quality, R&D, plant quality and manufacturing teams to transfer new products or site-to-site transfers, drive continuous improvement, and support an efficient, compliant transfer program with up to 30% travel.