Sr. Design Quality Engineer

2 weeks ago

Irvine, CA, United States E-Solutions Full time
Role: Sr. Design Quality Engineer

Location: Irvine, CA (Onsite)

Job Description:
  • Ensure quality engineering activities for released products comply with regulatory and internal standards.
  • Collaborate with cross-functional teams to develop product risk management documentation, including Risk Management Plans, Risk Assessments, DFMEA, and Risk Management Reports.
  • Support the development and execution of Verification and Validation (V&V) plans, protocols, and reports, Test Method Validation, as well as process. validation activities (PFMEA, IQ, OQ, PQ) using statistical tools (e.g., Minitab) for data analysis and decision-making.
  • Oversee product testing and analysis to ensure compliance with applicable standards and requirements.
  • Apply Design Control principles to support sustaining engineering efforts, including design updates and product enhancements.
  • Resolve quality issues, manage design changes, and assess risks in partnership with engineering, manufacturing, and quality teams.
  • Apply risk management techniques to proactively identify and mitigate product risks.
  • Use structured problem-solving methodologies to address product and process challenges.
  • Communicate findings effectively through presentations, technical reports, and cross-functional collaboration.

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