Quality Engineer

Quality Engineer Dynaflex Technologies Irvine, CA Job Details Full-time $71,000 - $85,000 a year 11 hours ago Benefits Health insurance Dental insurance Paid time off Qualifications Statistics Teamwork ISO standards Quality control statistical data analysis Corrective and preventive actions (CAPA) Bachelor's degree Quality inspection Manufacturing Root cause analysis FDA regulations Statistical analysis tools Full Job Description Job Summary The Quality Engineer independently performs quality engineering activities and supports manufacturing, supplier, and design quality functions. This role leads moderate-complexity investigations and drives continuous improvement initiatives within a regulated medical device environment. Key Responsibilities Lead root cause analysis and corrective and preventive action (CAPA) activities. Independently investigate nonconformances, deviations, and customer complaints. Review and approve manufacturing documentation, validation protocols, and reports and supplier audits when required. Support supplier qualification, audits, and incoming inspection strategies. Develop and maintain risk management documentation including FMEAs. Analyze quality metrics and drive process improvement projects. Participate in design reviews and change control evaluations. Support internal, customer, and regulatory audits. Travel Between Irvine and Yorba Linda facilities as needed. Qualifications & Experience Bachelor's degree in Engineering or related discipline or combination of education and . 1-5 years of quality engineering experience in medical devices or regulated industries. Working knowledge of

ISO 13485, FDA QSR, CAPA

systems, and validation requirements. Experience with statistical tools and root cause analysis methodologies. Core Competencies Independent problem-solving Data-driven decision making Cross-functional collaboration Regulatory compliance knowledge Effective written and verbal communication

Pay:

$71,000.00 - $85,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off

Work Location:

In person