Manufacturing Quality Engineer

1 month ago

Huntington, United States Source One Technical Solutions Full time
Job DescriptionJob Description

Seeking a Quality Engineer for a consulting position at a medical devices client in Huntington, WV.

Qualifications:
• Bachelor’s Degree in Science/Engineering or previous experience that would be the equivalent to a technical degree
• 2+ Years of experience in Pharmaceutical / Medical Device Industry
• Validation experience
• Project management experience
• ASQ CQE certification (or equivalent) preferred
• Understands statistical principles
• Experience in SAP/BI preferred

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.

Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.

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