Location: Huntington, WV
Position Type: Contract

Job Description:
* The Senior Quality Engineer I is responsible for working with the Quality, Manufacturing and MS&T Engineering teams to support activities during the overall product life cycle.
* The Sr. QE I will lead and support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, process controls, and validations.

MUST HAVES:
* Previous experience in Med Devise and Pharma (this needs to be clearly noted on the resume)
* Validation Experience
* Someone with a technical Degree or previous experience that would be the equivalent to a technical degree.

Job Responsibilities:
* Provides quality support to manufacturing operations including providing guidance on issue resolution, follow up on potential quality concerns, continuous improvement project support, and daily walk throughs.
* Investigates, approves, and/or provides input on minor and major non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA). Uses various statistical and non-statistical problem-solving tools to analyze data or issues and to identify/drive improvement opportunities.
* Tracks and trends CAPA system data with minimal guidance using various statistical and non-statistical problem-solving tools as part of analysis.
* Leads and supports medium to large size projects to reduce/prevent nonconformance events and/or projects to enhance the Quality Management System (QMS).
* Provides day-to-day Quality mentoring, assistance, and support to QE 1s and other departments (i.e., Manufacturing engineers, engineers, etc.) related to quality, compliance to regulatory standards, root cause investigations & investigation tools, risk management, validation concepts, general process challenges, and troubleshooting on the assigned projects/processes, including event identification and quarantine processes.
* Performs quality approval on various documents such as: SOP's/Work instructions/Job aids/Controlled Forms, technical reports, drawings, calibration/maintenance assessments and procedures, pre-qualification and validation documentation, and FMEAs.

Qualifications:
* Bachelor's Degree in Science/Engineering or Equivalent years of directly related experience (or high school 10 yrs; Assoc. 6 yrs; M.S. 0 yrs)
* 2 Years of experience in Pharmaceutical / Medical Device Industry preferred
* Project management experience
* ASQ CQE certification (or equivalent) preferred.
* Understands statistical principles.
* Experience in SAP/BI