Staff Quality Engineer (Microbiology)
Company: Endologix, Inc.
Posted on: October 14, 2020
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
* 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
* 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
* 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
* Familiarity with routine environmental monitoring, sterilization,
pyrogen testing and data trending programs.
* Demonstrated knowledge of and ability to apply GxP
* Prior interactions with domestic and international regulatory
* Ability to effectively work in an interdisciplinary setting.
* BS/BA or MS/MA degree in the biological or chemical sciences with
an emphasis on microbiology.
* 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
Endologix, Inc. is an Equal Opportunity/Affirmative Action
employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex including
sexual orientation and gender identity, national origin,
disability, protected Veteran Status, or any other characteristic
protected by applicable federal, state, or local law.
Keywords: Endologix, Inc., Irvine , Staff Quality Engineer (Microbiology), Engineering , Irvine, California
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