Quality Engineer (multiple positions)

Location: Rosemont, Illinois & other unanticipated work locations

Job Summary: The Quality Engineer is responsible for leveling of deviations/NCMs, investigating deviations to determine root cause utilizing industry-renown root cause tools (i.e. fishbone, is/is not, 6M), and determine effective corrective and preventative actions to prevent recurrence. Their duties may also include investigation and resolution of customer complaints, maintenance of a company’s Quality Management System (QMS), continuous improvement of quality standards associated with operational processes, and/or assisting validation of process/product.

Key Responsibilities:

  • Support manufacturing of pharmaceutical products
  • Actively participate and suggest solutions to problems and drive to timelines
  • Conduct direct contact with clients and internal customers across the site
  • Ensure that documentation is accurate and effectively assesses and mitigate risk associated with manufacturing activities
  • Suggest Corrective and Preventative Actions (CAPAs), take ownership for their deviations and drive to meet deadlines
  • Clearly articulate issues identified during the investigations and utilizing your strong technical writing skills to document those issues
  • Perform thorough deviation investigations (minor, major, critical)
  • Work cross-departmentally on determining proper correct actions and preventative actions based on root cause
  • Provide supervisory support to team and/or client team in the form of resource management, assistance with project deliverables, and process expertise
  • Conduct direct contact (face to face) with clients and internal customers
  • Work with client on maintaining schedules and understanding lot releases so these requirements can be cascaded to the remaining teams
  • Articulate issued identified during investigations and able to use strong technical writing skills to document these issues
  • Interpret FDA and other regulatory agency guidelines
  • Train junior and mid-level quality engineers on technical writing, how to conduct an acceptable investigation, root cause analysis and CAPA determination
  • Build new client relationships based on past successful Kneat Paperless projects
  • Support Kneat implementation projects for clients throughout the United States and Europe either as a lead, implementation engineer, or support engineer
  • Develop new relationships and focus substantial efforts on nurturing existing relationships
  • Fulfill contract requirements by ensuring that the duties and responsibilities of the project contract are clearly defined, documented, and followed
  • Prepare project specific staffing plans including man-hour estimates
  • Organize and prioritize a variety of complex projects and multiple tasks in an effective and timely manner, set priorities, and meet the critical time deadline
  • Serve as a Power User Level 1, 2, or Super User for Kneat Gx implementations
  • Able to conduct client trainings, if required
  • Support company’s content development, deployment and client implementation of our C&Q/CSV/CQV Package with Kneat Gx platform
  • Work with Director of Integrated C&Q and Paperless Strategy to identify additional areas of improvement and broaden the use of the Kneat Gx platform.

Required Skills & Experience:

  • Bachelor’s in Industrial Engineering, Quality Assurance, or related field and 2 years relevant engineering experience in Quality Engineer, Quality Assurance Specialist, or related position
  • This position also requires: 1 year of experience with as a Deviation Writer in junior to senior range; 1 year of GMP or other regulated industry experience; experience with FDA regulations; experience with Excellent technical writing; experience with deviation investigation and root cause analysis; experience with Corrective and Preventative Actions (CAPA) determination; experience with TrackWis; experience in performing root cause analysis (RCA) utilizing industry-acceptable tools, such as fishbone diagram, 5 Why’s, 6Ms, or Is/Is Not; experience with quality management systems and procedures; and experience with Kneat Gx software.

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