Diagnostics Operations Specialist

We have an exciting opportunity for a dedicated Diagnostics Operations Specialist to join our Quality Engineering team at Werfen. In this role, you will be responsible for planning and managing operations to ensure successful product realization and compliance with quality management systems.

Key Responsibilities:

Project Management: Lead cross-functional projects to establish priorities and goals for design and development.

Risk Management: Develop and maintain risk files in compliance with international risk management standards and regulations.

Process Validation: Ensure that processes are validated and compliant with regulatory requirements.

Qualifications:

Bachelor's degree or equivalent experience required; Advanced degree preferred.

5+ years' experience in an in vitro diagnostics environment, including 2 years in Quality Engineering or related roles; Supervisory experience required.

Technical writing experience; Experience with data collection and analysis.