Design Quality Engineer
E-Solutions
Title: Design Quality Engineer Location: Plano, TX (only onsite, no remote) JD:
- 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 - ISO13485, 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.
Vacancy posted 5 days ago
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