Quality Assurance Engineer II - Medical Devices & QMS

International Medical Industries, Inc.; Pompano Beach (FL); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading medical device company in Pompano Beach, FL is seeking a Quality Engineer II to support Quality Assurance and Engineering activities while ensuring compliance with relevant standards. The candidate will perform investigations, support CAPA, and participate in audits. A Bachelor's degree in engineering or science and 3–6 years of relevant experience are required. Strong communication skills and familiarity with ISO standards are essential. This position offers the chance to contribute to quality improvements in a dynamic environment.

Qualifications

• 3–6 years of Quality Engineering or Quality Assurance experience in a regulatory manufacturing environment.
• Hands-on experience with nonconformance investigations and CAPA execution.
• Working knowledge of ISO 13485 and FDA regulations.

Responsibilities

• Investigate product and process nonconformances using root cause analysis.
• Support CAPA development and effectiveness verification.
• Assist with internal and regulatory audits documentation preparation.

Skills

Root cause analysis

Quality Assurance

Statistical analysis

Cross-functional teamwork

Education

Bachelor’s degree in engineering or science

Job description

A leading medical device company in Pompano Beach, FL is seeking a Quality Engineer II to support Quality Assurance and Engineering activities while ensuring compliance with relevant standards. The candidate will perform investigations, support CAPA, and participate in audits. A Bachelor's degree in engineering or science and 3–6 years of relevant experience are required. Strong communication skills and familiarity with ISO standards are essential. This position offers the chance to contribute to quality improvements in a dynamic environment.