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Design Quality Engineer
Job in
Plano, Collin County, Texas, 75086, USA
Listed on 2026-02-16
Listing for:
Noblesoft Technologies
Full Time
position Listed on 2026-02-16
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering
Job Description & How to Apply Below
- 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
- 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)
- 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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