Support in Manufacturing process remediation and readiness activities for new product launch.
Support Design Transfer deliverables, including tracking and scheduling.
Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
Risk Management updates PFMEA.
Part creation in Windchill. BOM and configuration management.
Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements:
Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
Previous medical device experience
5+ years of Medical device Manufacturing experience
Numbers & Facts
Location
Morgantown, WV
Skills
Bill of Materials (BOM)unmatched
Change Requests/Ordersunmatched
Configuration Managementunmatched
Corporate Policiesunmatched
Cross-Functionalunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
ISO (International Organization for Standardization)unmatched
Machiningunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Operations Processesunmatched
Process Control Engineeringunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Product/Service Launchunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Team Playerunmatched
Windchill PLM Softwareunmatched
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