Job Overview
The primary responsibility of this role is to provide Quality Engineering support to various teams.
This involves offering assistance with process validation, change requests, non-conforming product issues, and the Corrective and Preventive Action program.
You will review validation documentation, change requests, design and process Failure Mode and Effects Analysis (FMEA)'s, test summaries, software validation, microbiological assessments, and critical system work orders.
Provide quality engineering support to research and development and sustaining engineering departments up to and including transfer to production, understanding design assurance activities, reviewing associated documents including design verification/design validation, design and process FMEA, process validation, and test summaries.
Support supplier appraisal and approval processes, liaise with production and quality control by providing quality engineering support to incoming quality control, in-process and final quality control, provide input and support to the Corrective and Preventive Action program (CAPAs), and the non-conforming product process.
Conducting, documenting, and reviewing complaint investigations, risk assessment of customer complaints, non-conformance, and CAPA's. Provide quality engineering support to the quality system, initiate, manage, and execute projects for continuous improvement within the department.
Provide meaningful quality measurement while ensuring that in-house or external quality issues are effectively prioritised and acted upon in a timely manner.