Supplier Quality Engineer

Role Summary

The Senior Supplier Quality Engineer oversees, evaluates, and manages quality issues for external suppliers, generating reports and presentations as needed. They assist in project management, statistical analysis, and training personnel.

Role Responsibilities

• Designs and executes Quality Engineering protocols
• Manages quality and process-related issues for suppliers
• Ensures compliance with manufacturer and Kindeva specifications
• Supports product development activities
• Interacts with third-party customers and outside testing laboratories
• Identifies and coordinates corrective actions for quality issues
• Ensures product traceability and quarantine as necessary
• Assists in compiling quality data and maintaining Quality System Records

Physical/Mental Requirements

• Exposure to work near moving mechanical parts
• Moderate noise levels in the work environment
• Occasional exposure to loud noise
• Stand, walk, sit, use hands, reach, talk, hear, lift up to 25 lbs., multi-task, handle multiple priorities, and work under strict deadlines

Education/Experience Requirements

• Bachelor's degree in an Engineering-related field
• Minimum 2 years of medical device or pharmaceutical Quality Engineering experience
• Familiarity with manufacturing processes and measurement gages
• Thorough knowledge of cGMPs, FDA guidelines, ISO standards, ASTM standards, etc.
• Certified Quality Engineer, Six Sigma training, or Lean Manufacturing training preferred

Skills

• Familiarity with medical device glass cartridge or vial, plastic injection molding, rubber compounding and molding, printed labels and packaging processes
• Knowledge of mechanical testing
• Good working knowledge of industry and regulatory guidance documents
• Excellent knowledge of protocol acceptance criteria and CAPA recommendations