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Sustaining Systems Design Quality Engineer Job Opening In Maple Grove – Now Hiring Katalyst HealthCares & Life Sciences


Job description


Responsibilities:
  • Ownership of design change projects including scoping, assessment, and implementation.


  • Develop, update, and maintain Design History File and Design Input / Output documentation.


  • Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.


  • Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.


  • Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.


  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.


  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

  • Requirements:
  • - Years with BS.

    Degree must be clearly stated on resume.


  • Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred.


  • Experience with design control, risk management, and medical device standards compliance.


  • Experience with corrective and preventive action.


  • Adaptable and effective collaborator in a team environment and in self-directed work.


  • Strong communication skills.


  • Required Skill Profession

    Engineers


    • Job Details

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    Unlock Your Sustaining Systems Potential: Insight & Career Growth Guide


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