Job Description

• Independent cleanroom monitoring:

• Execution and documentation of required tests (e.g., particles)

• Review of recorded data (e.g., temperature, pressure, humidity)

• Sending samples for external testing and reviewing results

• Defining measures for pest control and monitoring

• Defining the cleaning concept

• Providing technical support to departments regarding hygiene

• Contact person for customers regarding hygiene (e.g., in audits)

• Creation and handling of hygiene quarantine certificates

• Carrying out special measurements (e.g., in case of irregularities)

• Support with external complaints (e.g., conducting remeasurements)

• Creating and maintaining global hygiene documentation (e.g., hygiene layout)

• Defining and reviewing quality-related measures concerning changes affecting the cleanroom

• Approval of cleanroom items (e.g., overalls, disinfectants, cleaning agents, gloves, etc.)

Qualifications

Knowledge acquired through at least a 3-year education in a laboratory environment (e.g., microbiology, chemistry, biology, PTA, MTA) and expanded by at least three years of professional experience in a comparable role. This position requires specialized knowledge in hygiene monitoring related to medical devices.

• Good knowledge of hygiene monitoring and relevant regulatory requirements

• Confident handling of measurement tools and systems for hygiene monitoring

• Knowledge of quality management and relevant QM guidelines

• Good knowledge in the area of quality management systems

• Good IT user skills (e.g., MES / SAP, MS Office)

• Ensure the sustainable implementation of hygiene regulations in production.

Additional Information

All your information will be kept confidential according to EEO guidelines.