Quality Engineer
Categoria:
Healthcare / PharmaceuticalLuogo di lavoro:
Rovigo e provinciaFor our client, one of the largest global medical technology companies in the world, we are looking a Quality Engineer per a maternity leave contractQuality Engineering is responsible for product and service quality evaluation and control.
Works cross-functionally in the development and or maintenance of products or processes within the plant and with other company plants.
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.
Support different operations and company projects overseeing associated quality functions. Requisiti:
Demonstrates working knowledge of quality engineering policies, principles and best practices
Demonstrates working knowledge of ISO requirements
Applies statistical knowledge for sample size calculations to work for quality determination on projects of intermediate scope/complexity
Applies working understanding of regulatory requirements (cGMP, ISO, etc. )
to support work with mínimal supervision
Perform Risk Analysis for post-release product, systems and participate with Engineering in processes risk assessments.
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Applies knowledge and skills to a variety of standard activities for quality improvement and projects
Works with moderate guidance in own area of knowledge to make technical decisions about product or processes as part of calibration and non-conforming material reports.
Support internal and external audits
Main processes
Calibration system
Failure Investigation for Non-conforming product and complaints
Validation support / MSA
Provide different kind of reporting quality data information
MSA to support the organization
Participate in projects for quality or to support business needs from quality perspective
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