The Quality Specialist III is responsible for executing the Deviation/Nonconformity and Complaint Handling Processes within the Quality System. The QS III works on complex issues in which analysis of situations or data requires an in-depth evaluation of various factors. The QSIII exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The impact of errors in the QS III position is high. Errors could result in recall of products from the field or citations for regulatory noncompliance.
- Implements and monitors systems in support of FDA regulations and ISO standards, participating in and/or leading product/process investigations, and conducting in-depth product/process analysis.
- Writes and/or analyzes reports and recommends corrective actions for QIAGEN processes and products.
- Services as a resource for staff across all departments at QIAGEN on issues pertaining to product quality and will spend a significant amount of time directly interacting with staff across all departments at QIAGEN.
- Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards.