Sr Engineer (Quality)

Job Summary

Sr. Engineer who will analyze, implement, and execute processes to ensure product quality. Requires working in a cross-functional team environment including but not limited to members from Manufacturing, Clinical, Regulatory, and Marketing. No direct reports.

Responsibilities

• Utilizes project management skills to ensure timely completion of projects/programs, in support of corporate, plant, and/or departmental goals
• Supports and/or participates in in-depth internal and external audits
• Aids in the preparation for Management Review meetings
• Maintains and monitors various quality metrics
• Identifies opportunities for continuous improvement and customer satisfaction
• Compiles and represents data for monthly CAPA Review and Product Review meetings, as well as annual reports
• Gathers and analyzes data for root cause analysis
• Drives efforts to assure CAPAs are opened and completed appropriately
• Works with Engineering and Manufacturing to develop and implement corrective actions
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements
• Upholds quality system
• Serves as quality representative for New Product Development
• Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board