Senior CAPA & Product Transfer Engineer

Fresenius Medical Care; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Fresenius Medical Care is seeking a senior quality program leader to harmonize and standardize product transfer processes across regional/global areas. You will oversee quality at receiving sites and guide cross-functional teams through regulatory requirements and validation plans.

The role requires 6–8 years in quality, manufacturing or engineering within medical devices or pharma GMP environments, with strong collaboration skills and knowledge of FDA and MDR regulations.

Qualifications

• 6–8 years in Quality, Manufacturing and/or Engineering.
• Medical device/pharma GMP experience.
• Cross-functional collaboration proven.
• Knowledge of FDA, MDR/MDR regulations in medical devices/pharma.
• Engineering background required.
• Spanish language is a plus.

Responsibilities

• Lead harmonization and standardization of the product transfer process for the assigned regional/global area.
• Ensure product quality is achieved at the receiving manufacturing site during product transfer projects.
• Partner with CE quality, R&D, plant quality and manufacturing teams in transfers between sites.
• Ensure transfer projects comply with quality and regulatory requirements, with defined PFMEA, training, inspection and validation plans.
• Transfer reliable quality products into manufacturing through collaboration with value streams and operations.
• Develop receiving site quality metrics and oversee quality programs for transfers.
• Oversee and execute policies to ensure consistent outcomes and quality.
• Develop and implement quality and validation plans for new products at receiving facilities.
• Maintain compliance with FDA QSRs and ISO 13485.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

Medical devices

GMP environment

Project management

FDA regulations

Spanish language

Education

Bachelor's degree

Advanced degree desirable

Tools

PFMEA

Job description

Fresenius Medical Care is seeking a senior quality program leader to harmonize and standardize product transfer processes across regional/global areas. You will oversee quality at receiving sites and guide cross-functional teams through regulatory requirements and validation plans.

The role requires 6–8 years in quality, manufacturing or engineering within medical devices or pharma GMP environments, with strong collaboration skills and knowledge of FDA and MDR regulations.