IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Staff Quality Engineer (Microbiology)

Company: KORE1
Location: Irvine
Posted on: April 5, 2021

Job Description:


  • 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
    • 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: KORE1, Irvine , Staff Quality Engineer (Microbiology), Engineering , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Engineering Jobs

URGENT: Mechanic Wanted
Description: Looking for a mobile
Location: Van Nuys
Posted on: 04/17/2021

Phantom Works Lead Space Radar Analysis Engineer
Description: Phantom Works, Lead Space Radar System Analysis Engineer - El Segundo, CABoeing Phantom Works creates the next generation products and services for the Boeing Defense, Space Security business and is (more...)
Company: BOEING
Location: Los Angeles
Posted on: 04/17/2021

Lead ASIC - FPGA Development and Verification Engineer
Description: Position Overview:Boeing Defense Space Security seeks a Lead Digital ASIC/FPGA Design and Verification Engineer to support the Satellite Capabilities organization and multiple satellite product lines (more...)
Company: BOEING
Location: El Segundo
Posted on: 04/17/2021

Experienced Design and Analysis Engineer - Fleet Support (1st Shift)
Description: The Boeing Company is seeking a Diagnostic Algorithm and Trend Analysis DATA Team Engineer Level 4 to support Boeing Commercial customers in Seal Beach, California. Boeing Commercial Airlines BCA (more...)
Company: BOEING
Location: Seal Beach
Posted on: 04/17/2021

Lead RF/Microwave Hardware Subsystems Engineer
Description: At Boeing, we are all innovators on a mission to connect, protect, explore and inspire. From the sea bed to outer space, you'll learn and grow, contributing to work that shapes the world. Find your future (more...)
Company: BOEING
Location: Los Angeles
Posted on: 04/17/2021

13B Cannon Crewmember - Weapons Systems Technician
Description: As a Cannon Crewmember in the Army National Guard, you join a team that ensures the U.S. maintains its battlefield superiority. You'll deliver decisive blows to the enemy using howitzers and learn how (more...)
Company: Army National Guard
Location: Los Angeles
Posted on: 04/17/2021

Full Stack Engineer
Description: Sr. Full Stack Engineer - Streaming, Digital, Media Come join a leader in the Digtial Industry in delivering state of the art content to it's users on a Global Scale. Responsibilities Work with a team (more...)
Company: Ledgent Technology
Location: Los Angeles
Posted on: 04/17/2021

Senior Technical Security Risk Engineer
Description: ResponsibilitiesTheSenior Technical Security Risk Engineer collaborates with the UCLA HealthSciences IT community and leadership to conduct and promote comprehensiveanalyses of highly complex on premise (more...)
Company: UCLA Health
Location: Los Angeles
Posted on: 04/17/2021

Senior Principal Programmable Logic Engineer
Description: Category: Engineering br Location: Northridge, California br US Citizenship Required for this Position: Yes br Clearance Type: Secret br Telecommute: No -Teleworking not available for this position (more...)
Company: Northrop Grumman
Location: Northridge
Posted on: 04/17/2021

Enterprise Support Engineer
Description: More and more companies are using GitHub Enterprise, so the support team is growing. When our customers have problems, they contact us and it is our goal to help them as quickly and awesomely as possible. (more...)
Company: GitHub
Location: Los Angeles
Posted on: 04/17/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds