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:
The Quality Technician Molding & Assembly ensures the quality and compliance of medical components through advanced dimensional and visual inspections. This role is responsible for operating precision inspection equipment, analyzing data using Statistical Process Control (SPC), and supporting process improvements. The technician will also collaborate with cross-functional teams, improve processes, maintain quality records, and ensure adherence to ISO 13485 and FDA 21 CFR 820 standards.
Conduct dimensional and visual inspections for first article, gage R&R, process capability studies, and final product release.
Operate, program, and maintain inspection equipment such as CMMs, vision systems, and tool scopes, while ensuring equipment is calibrated and functioning properly.
Analyze inspection data using Statistical Process Control (SPC) to detect trends, monitor process stability, and recommend corrective actions to improve manufacturing processes.
Provide training to operators and quality personnel on proper inspection techniques, equipment usage, and documentation practices to ensure adherence to quality standards.
Support root cause analysis and CAPA activities, contributing to problem-solving efforts for non-conformance issues.
Perform DHR (Device History Record) reviews and ensure final lot release is completed per Good Documentation Practices (GDP) requirements.
Maintain accurate and timely quality documentation within the ERP system, ensuring traceability and compliance with company and regulatory requirements.
Collaborate with cross-functional teams, including engineering, production, and quality, to address quality concerns, implement process improvements, and ensure product conformance.
Ensure compliance with the company's Quality Management System (QMS), including ISO 13485, FDA 21 CFR 820, and other applicable medical device regulations.
Sustain an organized and cleanroom work environment using 5S principles to reduce waste and contamination risk in cleanroom operations.
Minimum of 3 years of experience in a regulated manufacturing environment, ideally in the medical device or a similar industry.
Knowledge of ISO 9001/13485 standards and regulatory compliance.
Experience working in a cleanroom environment
Relevant quality certifications, such as ASQ Certified Quality Technician (CQT) or equivalent.
Cretex Companies may 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
