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Quality Engineer I – Complaints
ICU MedicalQuality Engineer I at ICU Medical processing Medical Device customer feedback in a hybrid role. Involves project work on complaints with limited complexity and close supervision.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in processing and investigating Medical Device customer feedback while maintaining effective communication with internal and external stakeholders. Capable of conducting dimensional inspections and functional testing in a regulated environment, with a focus on quality assurance and collaboration.
Highest-signal resume keywords
Quality AssuranceDimensional InspectionRegulatory Vigilance ReportingEffective CommunicationTeam Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Dimensional Inspection RequestsStandardized Test MethodsFunctional Testing RequestsReport WritingLaboratory Techniques
Soft Skills
Effective CommunicationTeamworkAdaptabilityProblem-Solving
Industry Keywords
Medical DeviceRegulated ManufacturingPharmaceuticalHealthcareCustomer Feedback
About the role
Key responsibilities & impact- Methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner
- Identify critical dimensions on component drawings and submit dimensional inspection requests
- Carry out basic standardized test methods and/or submit functional testing requests
- Establish and maintain communication both internal and external (with the customers and regulatory personnel as needed)
- Domestic and International Regulatory vigilance reporting is essential
- Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
- References existing work to complete similar projects. Improves on previous work.
- Provides input to the product teams regarding the development of new designs, methods or processes.
- Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision.
- May assist in training new employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
- Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
- Work on special projects as they arise
Requirements
What you’ll need- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM)
- 0-2 years experience
- Prior experience in quality assurance is preferred.
- Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities