Quality Engineer Medical Device Manufacturing
Dynaflex Technologies Inc.
Summary
The Quality Engineer, Medical Device Manufacturing, is a full-time on-site role based in Irvine, CA. This role is responsible for overseeing product quality in catheter manufacturing, including developing and maintaining quality processes, procedures, and documentation in accordance with medical device regulations.
Job description
Day-to-day tasks include performing inspections and tests, analyzing quality data and metrics, investigating nonconformances, and implementing corrective and preventive actions (CAPA). The Quality Engineer collaborates closely with engineering, production, and supply chain teams to ensure compliant processes, robust validations, and continuous improvement of manufacturing operations. The role also supports internal and external audits, risk management activities, and alignment with customer and regulatory requirements.
Qualifications
- Demonstrated skills in Quality Engineering and Quality Management for medical device manufacturing.
- Experience in Quality Control methods, including inspection techniques, testing, and data analysis.
- Proficiency in Quality Assurance activities, such as documentation control, audits, and compliance with ISO 13485 and FDA regulations.
- Ability to manage Product Quality, including root cause analysis, CAPA, and continuous improvement initiatives.
- Bachelor's degree in Engineering, Science, or a related technical field; advanced degree or relevant certifications (e.g., CQE) are a plus.
- Familiarity with catheter manufacturing processes, extrusion, and cleanroom production environments preferred.
- Experience with validation (IQ/OQ/PQ), statistical process control, and risk management tools (e.g., FMEA).
- Strong communication skills and ability to work collaboratively with cross-functional teams in a regulated environment.
Requirements
- Demonstrated skills in Quality Engineering and Quality Management for medical device manufacturing.
- Experience in Quality Control methods, including inspection techniques, testing, and data analysis.
- Proficiency in Quality Assurance activities, such as documentation control, audits, and compliance with ISO 13485 and FDA regulations.
- Ability to manage Product Quality, including root cause analysis, CAPA, and continuous improvement initiatives.
- Bachelor's degree in Engineering, Science, or a related technical field.
- Experience with validation (IQ/OQ/PQ), statistical process control, and risk management tools (e.g., FMEA).
- Strong communication skills and ability to work collaboratively with cross-functional teams in a regulated environment.
- Advanced degree or relevant certifications (e.g., CQE) are a plus.
- Familiarity with catheter manufacturing processes, extrusion, and cleanroom production environments preferred.
Company overview
Dynaflex Technologies Inc. is a global contract development and manufacturing organization (CDMO) headquartered in Yorba Linda, California, specializing in catheter solutions, polymer innovations, and advanced manufacturing equipment for the medical device industry. Founded in 2014, the company provides end-to-end services from rapid prototyping to high-volume commercial production, with expertise in catheter assemblies, thermoplastic extrusion, multi-lumen tubing, braided/coiled shafts, steerable catheters, and high-performance coatings. Dynaflex operates strategically located facilities including a rapid prototyping lab in Fremont, design validation and clinical build operations in Irvine, a polymer solutions hub in Yorba Linda, and a high-volume production facility in Taiwan. The company is FDA registered and ISO-13485 certified, serving leading medical device companies across neurovascular coil delivery, heart valve repair catheters, steerable EP catheters, atherectomy and thrombectomy devices, and stent delivery systems. Dynaflex also develops PFAS-free material platforms such as EverGlide+ and AI-driven manufacturing equipment, positioning itself as a trusted innovation partner from concept to commercialization.