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Staff Quality Engineer (Microbiology)

Company: KORE1
Location: Irvine
Posted on: April 5, 2021

Job Description:

Responsibilities:

  • Assure that activities are in compliance with the respective areas that are applicable from FDA GMP/GLP, ISO 10993, 13485, 25539, CMDR, CMDCAS, euMDR, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other national and international standards as applicable.
  • Own the design and execution of biocompatibility and chemical characterization studies. Schedules projects to ensure that deadlines are met.
  • Anticipate issues and troubleshoot complex technical problems.
  • Oversee qualification/verification of analytical test methods and instrumentation including supporting documentation, procedures, protocols and reports.
  • Contributes to out of specification (OOS) and/or microbial testing laboratory investigations.
  • Provide data review, process trending, and procedural updates and provide technical support for sterilization validation protocol writing as needed.
  • Validate, if required, improvements to current methods.
  • Schedules projects to ensure that deadlines are met.
  • Support internal and external audits as the biocompatibility subject matter expert. Act as the back up SME for microbiology, sterilization, pyrogen, bioburden, and environmental monitoring as needed.
  • Support sustaining and new product projects.
  • Be self-directed with the ability to take initiative and be accountable for results, and demonstrate confidence, maturity and integrity.
  • Communicate effectively to all levels of an organization.
  • Ability to prioritize work activities to ensure critical priorities; those with highest impact on goals.
  • Strong verbal, technical writing and interpersonal skills are required. Project Management and prioritization skills. Audit and Investigation Skills, Report Writing Skills.
  • Position may require infrequent (-1x/quarter) domestic travel
    Qualifications:
    • Experience in biocompatibility testing requirements and contract lab management.
    • Familiarity with routine environmental monitoring, sterilization, pyrogen testing and data trending programs.
    • Demonstrated knowledge of and ability to apply GxP regulations
    • Prior interactions with domestic and international regulatory agencies.
    • Ability to effectively work in an interdisciplinary setting.
      Minimum Education:
      • BS/BA or MS/MA degree in the biological or chemical sciences with an emphasis on microbiology. Minimum Experience:
        • Eight years with a Bachelor's degree, Five years with a Master's degree or a PhD, of directly relevant experience. Class III medical device experience strongly preferred.
        • Polymer manufacturing experience preferred

Keywords: KORE1, Irvine , Staff Quality Engineer (Microbiology), Engineering , Irvine, California

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