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Endologix, Inc Staff Quality Engineer (Microbiology) in Irvine, California

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.

  • 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

  • · 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

ID: 2021-2430

External Company Name: Endologix

External Company URL: http://www.endologix.com/

Street: 2 Musick

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