Quality Systems Quality Engineer I - Fresenius Medical Care
Software Engineer
Entry‑level Quality Engineer focused on FDA‑compliant quality systems, risk management, and validation within a medical device manufacturing environment.
About the role
Key Responsibilities
Develop, review, and improve facility Quality Plans and manufacturing processes in alignment with FDA and industry standards.
Manage and update product Risk Management Files, ensuring accurate documentation and traceability.
Coordinate information exchange and best practices with other FMCNA facilities to maintain consistency across sites.
Assist in the preparation and execution of internal and external audits, addressing findings and implementing corrective actions.
Support validation activities, including process validation, equipment qualification, and method validation.
Requirements
Bachelor’s degree in Engineering, Life Sciences, or related field.
Strong understanding of FDA regulations (21 CFR Part 820) and GMP principles.
Experience with risk management tools (e.g., FMEA, HACCP) and validation documentation.
Excellent written and verbal communication skills for cross‑functional collaboration.
Detail‑oriented mindset with the ability to manage multiple tasks in a regulated environment.