Product Builder I
Under supervisory direction, functions as a member of a production team whose goal is to assemble required components, operate equipment, inspect in-process medical devices / kits, and maintain the quality and integrity of the products at all times. Primary focus is to build product by following processes to meet production goals. Must be able to communicate clearly with co-workers both in speech and in writing.
• Builds product by following all processes in which certified (most current revision) and complete other assigned work while meeting production goals and metrics.
• Responsible for quality and 100% adherence to manufacturing process requirements, the Corporation Quality Policy and the Strategic Quality Process (SQP).
• Proactively identifies and communicates quality issues and concerns.
• Maintains accurate records including training and shop floor paperwork (SFP).
• Willing to participate in shared responsibilities and tasks.
• Champions the “flex strategy”, rotates as necessary and works well with group members, both within the team and cross-functionally.
• Demonstrates proficiency in all communication, including written and spoken.
• Demonstrate an understanding of the basic functions of SAP.
• Ability to use computers at a basic level.
• Understand and apply Core 5 Metrics in relation to the daily tasks.
• Must have working knowledge of all processes in assigned area.
• Understands and ensures compliance of company, site specific and regulatory policies and procedures.
• Responsible for attending and passing all required core company and site specific training (i.e. QS Basics, GDP, cGMP).
• Participate in team meetings.
• Participate during site internal audits and third party inspections.
• Other tasks as directed by the Production Supervisor, Production Manager, and/or Quincy Site Leadership.
• Participate in continuous and process improvements/efforts.