Cleanroom Quality Technician – Calibration & Validation

The Cretex Companies; Brooklyn Park (MN); On-site; USD 32,000 - 45,000; Full time

Job summary

Cretex Medical, a leading contract manufacturer for the medical device industry, seeks a Quality Engineering Technician to manage environmental monitoring, calibration, and documentation in cleanroom environments. The role ensures ISO/AAMI/ASTM compliance and supports continuous improvement in manufacturing processes.

Responsibilities include performing monthly environmental monitoring, coordinating testing with external labs, maintaining calibration schedules, and supporting validation

Qualifications

• Associate degree in a technical field is required.
• 2–5 years in a quality role within a regulated environment, preferably medical device manufacturing or cleanroom operations.
• Experience with ISO Class 7 and Class 8 cleanrooms and environmental monitoring techniques.
• Experience with equipment calibration and maintenance, including managing calibration schedules and records.
• Strong organizational skills and attention to detail; able to manage multiple tasks.
• Excellent written and verbal communication; strong technical writing and documentation.
• Familiarity with AAMI, ASTM, and ISO standards related to medical device sterilization and cleaning.
• Ability to read and interpret engineering drawings, including GD&T.

Responsibilities

• Environmental Monitoring, Testing, and Reporting in Class 7/8 cleanrooms.
• Coordinate with external labs for testing and compile environmental reports.
• Maintain environmental monitoring documentation and ensure regulatory compliance.
• Assist engineering in validation and verification activities.
• Update cleanroom and calibration documentation; audit readiness.
• Perform sterilization and cleaning tests; support dose audits and EO re-qualification.
• Monitor, inspect, and calibrate manufacturing and cleanroom equipment; manage calibration schedules.

Skills

Quality systems

Environmental monitoring

Calibration & maintenance

Documentation & records

GD&T

Technical writing

Education

Associate degree in Engineering or related field

Biology/Microbiology background

Tools

Calibration management software

Cleanroom testing equipment

Job description

Cretex Medical, a leading contract manufacturer for the medical device industry, seeks a Quality Engineering Technician to manage environmental monitoring, calibration, and documentation in cleanroom environments. The role ensures ISO/AAMI/ASTM compliance and supports continuous improvement in manufacturing processes.

Responsibilities include performing monthly environmental monitoring, coordinating testing with external labs, maintaining calibration schedules, and supporting validation