Global Product Transfer Quality Engineer (CAPA Lead)

Fresenius Medical Care; Waltham (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Job summary

Fresenius Medical Care in Waltham, MA seeks a seasoned professional to lead global product transfer processes. You will harmonize transfer standards, ensure receiving-site quality, and drive cross-functional collaboration across CE quality, R&D and manufacturing.

The role requires 6–8 years in quality/manufacturing/engineering within regulated environments and strong GMP/regulatory knowledge. Travel up to 30% may be needed.

Qualifications

• 6–8 years of experience in Quality, Manufacturing or Engineering.
• Medical device/pharma regulated industry experience preferred.
• GMP environment experience is expected.
• Experience with FDA/MDD/MDR regulations is desirable.

Responsibilities

• Lead the harmonization and standardization of product transfer processes.
• Ensure product quality at receiving sites during transfers.
• Collaborate with CE quality, R&D, plant quality and manufacturing teams.
• Develop quality and validation plans and update procedures as needed.

Skills

Cross-functional collaboration

Communication skills

Continuous improvement

GMP/regulatory knowledge

Education

Bachelor's Degree

Advanced Degree desirable

Job description

Fresenius Medical Care in Waltham, MA seeks a seasoned professional to lead global product transfer processes. You will harmonize transfer standards, ensure receiving-site quality, and drive cross-functional collaboration across CE quality, R&D and manufacturing.

The role requires 6–8 years in quality/manufacturing/engineering within regulated environments and strong GMP/regulatory knowledge. Travel up to 30% may be needed.