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Associate Project Manager, Medical Device
Fresenius Kabi USA. Coordinate, communicate and support the Lake Zurich biocompatibility program for high-volume material qualification projects .
Posted 11/11/2026full-timeLake Zurich • Illinois • United StatesMid-Level💰 $75,000 - $80,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in biocompatibility program coordination and material qualification processes, with a strong focus on compliance with regulatory standards such as ISO 10993 and 21 CFR Part 58. Proficient in managing documentation and communication for biocompatibility studies and risk assessments.
Highest-signal resume keywords
Biocompatibility Program CoordinationISO 10993 FamiliarityProject Management ExperienceAnalytical Communication SkillsCRO Relationship Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biocompatibility TestingRisk AssessmentGap AnalysisMaterial QualificationProtocol PreparationReport ReviewChemistry AssessmentsStudy Documentation ManagementRegulatory ComplianceSupplier Quality Audits
Soft Skills
Attention to DetailAnalytical SkillsOral CommunicationWritten CommunicationCollaboration
Tools & Technologies
Microsoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft PowerPointInternet Applications
Industry Keywords
21 CFR Part 58ISO 14001ISO 45001USPPhEur Chapter 3Contract Research OrganizationMaster Service AgreementsNon-Conforming Test ResultsMaterial Qualification PoliciesHigh-Volume Material Qualification
About the role
Key responsibilities & impact- Coordinate, communicate and support the Lake Zurich biocompatibility program for high-volume material qualification projects
- Administer requirements, processes, procedures, sample handling and documentation for compliant biocompatibility studies
- Coordinate outsourced biocompatibility studies, chemistry assessments and related activities
- Prepare, review and approve protocols and reports for materials qualification and biocompatibility testing
- Support testing through risk assessment, gap analysis and documentation
- Identify and communicate risks and support response strategies
- Support engineering colleagues with materials qualification documentation
- Develop and maintain medical device material qualification policies and standards
- Prepare and review nitrosamine and elemental impurities risk assessments
- Coordinate Contract Research Organization relationships and support Master Service Agreements
- Participate in supplier quality laboratory audits
- Coordinate and review CRO study protocols and reports
- Assure CRO conformance with regulations including 21 CFR Part 58 (GLP)
- Communicate findings, investigate non-conforming test results and collaborate to resolve issues
- Report qualification results to project teams
- Manage retrieval of material qualification results in a growing database
- Provide study cost estimates to Project Engineers and Directors
- Manage and archive study documentation in the official documentation system
- Support occupational, environmental and integrated management system compliance under ISO 14001 and ISO 45001
Requirements
What you’ll need- Bachelor’s Degree in chemistry, biology, or another related discipline is required
- Minimum 3 years of experience in a related role
- 1 year of project management experience preferred
- Familiarity with ISO 10993-1 and related parts, including ISO 10993-18 and ISO 10993-19
- Familiarity with USP and PhEur Chapter 3
- Advanced knowledge of Outlook, Word, Excel and PowerPoint
- Proficiency with Internet/Intranet applications and research
- Demonstrated success coordinating outsourced scientific service providers
- Demonstrated experience coordinating scientific studies
- High attention to detail and excellent analytical, oral and written communication skills
- English proficiency: ability to speak, read, write and understand English
- Applicants must be authorized to work for any employer in the United States; visa sponsorship is unavailable
Benefits
Comp & perks- Bonus plan with a target of 6% of base salary
- 401(k) plan with company contributions
- Paid vacation, holiday and personal days
- Employee assistance program
- Medical, prescription drug, dental and vision coverage
- Life insurance
- Disability coverage
- Wellness program