The Quality Associate plays a critical role in supporting and maintaining the organisation's quality management system (QMS) and ensuring compliance with regulatory requirements. This position serves as a key contributor to quality assurance initiatives, document control processes, and training coordination while supporting data integrity and process improvement activities. The Quality Associate acts as a liaison between various departments to ensure quality standards are met and maintained across all operational areas.
Key Responsibilities:
Document Management & Control
- Upload and Quality Approval of Standard Operating Procedures (SOPs), Work Instructions (WINs), and policies to the electronic Quality Management System (eQMS)
- Develop and maintain standardized templates for quality documentation
- Conduct comprehensive gap analyses on procedures and process approaches
- Ensure document version control and compliance with regulatory standards
Training Management & Coordination
- Monitor training management activities within the eQMS platform
- Collaborate with line managers to ensure training plans are relevant, current, and effectively implemented
- Generate and analyse training reports to track completion rates and identify training gaps
- Support the development and delivery of quality-related training programs
Quality Event Management
- Serve as the primary point of contact for quality events and issue management
- Coordinate investigation activities and ensure timely resolution of quality issues
- Maintain accurate records of quality events and corrective/preventive actions (CAPA)
Client Support & Process Qualification
- Work with Sales and PM team to support qualification processes/questionnaires from prospective/ active customers
- Coordinate with cross-functional teams to ensure client requirements are met
Data Management & Reporting
- Gather, compile, and enter data for Key Performance Indicators (KPIs) and Quality Engagement Index metrics
- Generate regular quality reports
- Analyse quality data to identify trends and improvement opportunities
Job Type: Full-time
Pay: 3.175,00€ per month
Work Location: Hybrid remote in Biedermannsdorf, NÖ
Application Deadline: 01/08/2025
Expected Start Date: 11/08/2025
