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Quality Engineer

1 month ago

Warwick, United States MILLENNIUMSOFT Full time

Position: Quality Engineer (Must have Design Control)

Location: Warwick, RI

Duration: 12+ Months Contract

Total Hours/week: 40.00

Description:

Candidates must have Design Control experience
Quality Engineering is responsible for product and service quality evaluation and control.

  • Works cross-functionally in the development and or maintenance of products or services.
  • The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
  • Demonstrates basic knowledge of quality engineering policies, principles and best practices.
  • Demonstrates basic knowledge of FDA/ISO/EUMDR requirements.
  • Applies basic statistical sample size calculations to work for quality determination on simple projects.
  • Applies basic understanding of regulatory requirements (cGMP, FDA, ISO, EUMDR, etc.) to support work with direct supervision.
  • Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.
  • Has basic knowledge of theories, practices and procedures in a job family or skill.
  • Applies knowledge and skills to complete own work. Depends on others for instruction