Sr. Design Quality Engineering

7 days ago

Irvine, CA, United States Katalyst Healthcares and Life Sciences Full time
Job Summary:
  • Ensure quality engineering activities for released products comply with regulatory and internal standards while supporting risk management, verification & validation, process validation, and sustaining engineering activities.

Roles & Responsibilities:
  • 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.
  • pply 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.
  • pply 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.
Education & Experience:
  • Experience supporting Verification & Validation, process validation, risk management, and sustaining engineering activities.
  • Proficiency in using statistical tools such as Minitab for data analysis.
  • Knowledge and experience applying Design Controls and risk management techniques in engineering environments.
  • bility to work collaboratively across engineering, manufacturing, and quality teams.

  • Sr. Design Quality Engineering

    6 days ago

    Irvine, CA, United States Simarn Solutions Full time

    About the job Sr. Design Quality Engineering Sr. Design Quality Engineering Location: Irvine, California Job Type: C2C | Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk...

  • Sr. Design Quality Engineering

    2 weeks ago

    Irvine, CA, United States Simarn Solutions Full time

    About the job Sr. Design Quality Engineering Sr. Design Quality Engineering Location: Irvine, California Job Type: C2C | Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk...

  • Sr. Design Quality Engineering

    2 days ago

    Irvine, CA, United States Simarn Solutions Full time

    About the job Sr. Design Quality Engineering Sr. Design Quality Engineering Location: Irvine, California Job Type: C2C | Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk...

  • Sr. Design Quality Engineering

    7 days ago

    Irvine, CA, United States Simarn Solutions Full time

    About the job Sr. Design Quality Engineering Sr. Design Quality Engineering Location: Irvine, California Job Type: C2C | Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk...

  • Sr. Design Quality Engineering

    2 weeks ago

    Irvine, CA, United States Simarn Solutions Full time

    About the job Sr. Design Quality Engineering Sr. Design Quality Engineering Location: Irvine, California Job Type: C2C | Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk...

  • Sr. Design Quality Engineer

    7 days 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...

  • Sr. Design Quality Engineer

    6 days ago

    Irvine, CA, United States Katalyst CRO Full time

    Sr. Design Quality Engineer at Katalyst CRO Responsibilities 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...

  • 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...

  • Sr. Design Quality Engineer

    2 weeks ago

    Irvine, CA, United States Katalyst CRO Full time

    Sr. Design Quality Engineer at Katalyst CRO Responsibilities 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...

  • Sr. Design Quality Engineer

    7 days ago

    Irvine, CA, United States Katalyst CRO Full time

    Sr. Design Quality Engineer at Katalyst CRO Responsibilities 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...