Design Quality Engineer

Job Summary:

• 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.