Quality Engineering Technician - Cleanroom & Calibration Management - Cretex Medical Component and Device Technologies

Overview

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com. Position Summary: Cretex Medical is seeking a Quality Engineering Technician to oversee the operations of our production and cleanroom environments. This role is pivotal in ensuring compliance with cleanroom standards and maintaining the calibration of equipment to uphold product quality and regulatory requirements. The successful candidate will conduct environmental monitoring, manage equipment calibration, perform inspections, and support continuous improvement initiatives.
Responsibilities

Environmental Monitoring, Testing, and Reporting

• Conduct monthly environmental monitoring (particulate and microbial testing) in Class 7 and Class 8 cleanrooms.
• Coordinate with external labs for testing and compile environmental reports, analyzing data to identify trends and implementing corrective actions as needed.
• Complete all activities for the environmental monitoring program to ensure regulatory compliance.

Validation, Documentation, and Calibration

• Assist engineers in validation and verification activities, supporting compliance and process integrity.
• Update and maintain cleanroom and calibration documentation, ensuring audit readiness.
• Perform sterilization and cleaning tests, supporting study requirements, routine radiation dose audits, and EO re-qualification.
• Monitor, inspect, set up, calibrate, and maintain manufacturing and cleanroom equipment, managing calibration schedules and coordinating with outside calibration services as needed.

Process Audits and Quality Improvement

• Conduct process audits to verify adherence to 5S standards and quality protocols.
• Participate in root cause analysis and corrective actions to resolve non-conformances and support CAPA and customer complaint processes.
• Support continuous improvement initiatives to enhance cleanroom practices, equipment reliability, and quality-related processes.

Training, Compliance, and Technical Skills

• Provide training and guidance to staff on cleanroom protocols, equipment usage, and calibration procedures.
• Apply blueprint reading and GD&T knowledge to support inspection and process quality.
• Ensure documentation and activities comply with ISO standards and regulatory requirements, maintaining an audit-ready state.

Qualifications

Job Requirements:

• Associate degree in Engineering, Biology/Microbiology, or a related technical field.
• 2-5 years in a quality role within a regulated environment, preferably in medical device manufacturing or cleanroom operations.
• Proficiency in cleanroom standards (ISO Class 7 and Class 8) and environmental monitoring techniques.
• Experience with equipment calibration and maintenance, including managing calibration schedules and records.
• Strong organizational skills with attention to detail and the ability to manage multiple tasks effectively.
• Excellent verbal and written communication skills, with proficiency in technical writing and documentation.
• Familiarity with applicable AAMI, ASTM, and ISO standards related to medical device sterilization and cleaning.
• Ability to read and interpret engineering drawings and specifications, including Geometric Dimensioning and Tolerancing (GD&T).

Physical & Environmental Demands:

Cretex Companies use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels.

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right."
• "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corpora