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
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