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.
· 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
External Company Name: Endologix
External Company URL: http://www.endologix.com/
Street: 2 Musick