On-Site 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

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