Quality Engineer (SRG)

Quality Engineer (SRG)
  • Competitive
    HOUR
  • Permanent
  • Irvine CA, US Irvine ORANGE US 92618
Job Ref: JO000115669
Sector: Clinical
Sub-sector: Quality
Date Added: 16 April 2021

SRG is a Global Life Sciences staffing and consulting firm and we are seeking a Staff QE-Microbiology with a strong understanding of the ISO regulations for Biocompatibility and have experience with blood contact devices.

Overview

Primary responsibilities will be to support, plan, manage, and execute the daily, short-term and long-term activities, and goals associated with biocompatibility requirements. In addition, acts as a consultant for environmental monitoring, sterilization, pyrogen and bioburden testing programs to support the manufacturing of various AAA devices.

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
  • Perform other duties as assigned by supervisor

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

SRGTalent
29/05/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Kayla Sanford

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