Design Quality Engineer
Listed on 2026-07-01
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Engineering
Quality Engineering, Biomedical Engineer, Medical Device Industry
Job Title
6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development.
Good experience in Medical devices regulations – ISO
13485, FDA & EU MDR regulations
Experience in compiling Design history files & Technical file submission for 510k & CE mark
Own Risk Management files – Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report
Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.
Review & approve all the design history files with cross functional teams (including software deliverables)
Support product development equipment qualification activities, test method development and validation activities.
Strong in Medical devices technical documentation
Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
Strong analytical/problem solving, critical thinking, and presentation skills.
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