Biocompatibility Project Coordinator - Medical Devices

Fresenius Kabi; Lake Zurich (IL); On-site; USD 75,000 - 80,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Health benefits (medical, dental, and視

Job summary

Fresenius Kabi USA is seeking an Associate Project Manager to support biocompatibility material qualification activities for the Transfusion and Cell Therapies division. You will coordinate outsourced studies, prepare protocols, and ensure compliant execution of testing under ISO and regulatory standards.

The role involves working under supervision, with a focus on documentation, risk assessment, and collaboration with CROs and internal teams.

Qualifications

• Bachelor’s Degree in chemistry, biology, or other related discipline is required.

Responsibilities

• Coordinate Fresenius Kabi Lake Zurich Biocompatibility program for numerous material qualification projects per ISO standards and regulatory guidance.
• Prepare, review and approve protocols and reports for materials qualification and biocompatibility testing.
• Support risk assessment, gap analysis and documentation; communicate risks and response strategies.
• Assist engineering with preparation of materials qualification documentation.
• Develop and maintain policies for processes of medical device material qualification, including nitrosamine and elemental impurities risk assessments.
• Coordinate CRO relationships and supplier quality lab audits.
• Review study protocols and CRO reports for regulatory conformance (21 CFR Part 58, GLP).
• Report results and manage a database of material qualification results.
• Provide cost estimates for studies to Project Engineers/Directors.
• Ensure all study documentation is archived in the official system.

Skills

Bachelor’s degree in chemistry, or a相关

Project management

ISO 10993 knowledge

Analytical skills

Communication skills

Education

Bachelor’s Degree in chemistry, biology, or related discipline

3 years experience in related role

Tools

Microsoft Office

Job description

Fresenius Kabi USA is seeking an Associate Project Manager to support biocompatibility material qualification activities for the Transfusion and Cell Therapies division. You will coordinate outsourced studies, prepare protocols, and ensure compliant execution of testing under ISO and regulatory standards.

The role involves working under supervision, with a focus on documentation, risk assessment, and collaboration with CROs and internal teams.