cGMP Quality Engineer

Category: Life Science

Employment Type: Contract

Reference: BH-362666-2

We have a contract opportunity for a Quality Engineer in Huntington West Virginia. This position is initially approved for 18 months and could be extended.

Pay Rate:$35.72/Hr.

Summary:
The 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 Quality Engineer will lead and support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, process controls, and validations.

Experience:

• Previous experience in Med Device and/or Pharma
• Validation Experience
• Technical Degree or previous experience that would be the equivalent to a technical degree.

• 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 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.

• Bachelor's Degree in Science/Engineering or Equivalent years of directly related experience (or high school 10 years; Assoc. 6 years; M.S. 0 years)
• 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