Staff Quality Engineer (Microbiology)

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

Job Description:

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

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