Quality Engineering Technician
Cretex Medical Component and Device Technologies
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.
Job description
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.
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).
Benefits
- 401(k) Matching
- Onsite Health Clinics
- Discretionary Holiday Bonus
- Cretex University
- Employee Assistance Program
- Wellness Program
- Employee Death Benefit
- Sick and Safe Leave
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account
- Paid Holidays
- Paid Time Off
- Profit Sharing
- Parental Leave
- Accident & Critical Illness
- Life Insurance
- Short & Long Term Disability
- Tuition Assistance
Company overview
Cretex Medical Component and Device Technologies is a specialized medical device manufacturing company that focuses on producing precision components and complete device assemblies for the healthcare industry. The company operates as a contract manufacturer and supplier of critical medical components, serving original equipment manufacturers (OEMs) in various medical sectors. Their expertise lies in manufacturing complex medical device components that require high precision, strict quality control, and compliance with rigorous medical standards. The company's capabilities typically include injection molding, machining, assembly, and finishing processes for medical devices. They work with a range of materials suitable for medical applications, including various plastics, metals, and biocompatible materials. As a medical device component manufacturer, Cretex plays a crucial role in the medical device supply chain by providing OEMs with reliable, high-quality components that meet regulatory requirements for safety and efficacy. Their services help medical device companies bring innovative healthcare solutions to market while maintaining cost-effectiveness and manufacturing excellence.