Quality Engineer Medical Device Manufacturing

Dynaflex Technologies Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

DynaFlex Technologies Inc. in Irvine, CA is seeking a Quality Engineer, Medical Device Manufacturing, to oversee product quality in catheter manufacturing and to develop and maintain quality processes and documentation in line with medical device regulations.

You will perform inspections and tests, analyze quality data, investigate nonconformances, implement CAPA, and collaborate with engineering, production, and supply chain to ensure compliant processes and robust validations, while supporting

Qualifications

• Experience in Quality Engineering and Quality Management for medical device manufacturing.
• Proficiency in QA activities, 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.
• Familiarity with validation (IQ/OQ/PQ) and risk management tools (e.g., FMEA).

Responsibilities

• Oversee product quality in catheter manufacturing and maintain quality processes and documentation.
• Perform inspections and tests, analyze quality data, and investigate nonconformances.
• Lead CAPA programs and collaborate with engineering, production, and supply chain.
• Support internal and external audits and align with regulatory requirements.

Skills

Quality Engineering

Quality Management

Quality Control

Quality Assurance

CAPA

Root cause analysis

Cross-functional collaboration

Validation IQ/OQ/PQ

Statistical process control

FMEA

Education

Bachelor's degree in Engineering/Science or related field

CQE certification

Job description

Company Description

DynaFlex Technologies Inc. is a global contract manufacturer specializing in catheter assemblies and thermoplastic extrusion for the medical device industry. The Corporate Headquarters in Irvine and Yorba Linda focuses on catheter technology development and advanced melt extrusion. A Rapid Prototyping Lab in Fremont supports quick-turn delivery systems prototyping and process development. The production facility in Taiwan provides turnkey contract manufacturing services for high-volume commercial builds, enabling end-to-end solutions from concept to scaled production. Team members collaborate across locations to deliver high-quality, innovative products to medical device partners worldwide.

Role Description

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. 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.