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Quality Engineer

Company: Katalyst HealthCares & Life Sciences
Location: Redwood City
Posted on: May 26, 2023

Job Description:

Job Description

Job Description:

  • Perform process documentation line audit/walkthrough/assessment for each MPI/QI/WI
  • Identify, review, and update Equipment gaps and qualification documents
  • Review Forms for accuracy and identify improvements
  • Identify, review, and update process MPI/QI/WI gaps related to Practice vs Procedure
  • Review and/or Create process validation protocols, process optimization studies, and generate verification/validation reports
  • Identify and create control plans within the manufacturing process (i.e. daily power reading, power measurement method etc...)
  • Review and/or update IQ/OQ/PQ for equipment/s that require process validation/verification
  • Provide support to day-to-day manufacturing activities (as needed) related to NCMR, Process
  • Deviations, Drawings, manufacturing documents, in process and final inspection, testing etc..
  • Escalate issues to cross functional team as appropriate
  • Bring process improvement ideas and drive solutions to completion
  • Work cross-functionally with production, quality, R&D
  • Maintain trained status for, and comply with, all relevant aspects of the Quality Management
  • System to ensure product and support regulatory compliance
  • Understand and adhere to the EHS policy QUALIFICATIONS (Education, Experience, Certifications)
    • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
    • The requirements listed below are representative of the knowledge, skill, and/or ability required.
    • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • BS in Mechanical Engineering, Mechatronics, STEM or Quality related education or a similar engineering discipline required, Master's degree preferred.
    • At least 5+ years of progressive experience in medical device quality engineering, manufacturing.
    • Working knowledge of 21CFR 820, ISO13485, EU-MDR requirements for medical device manufacturers.
    • ASQ CQE, CQA certification a plus
    • Demonstrated reasoning ability to apply principles of logical or scientific and critical thinking to a wide range of intellectual and practical problems

Keywords: Katalyst HealthCares & Life Sciences, Redwood City , Quality Engineer, Engineering , Redwood City, California

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