Quality Engineer
MRI Tallahassee
We are seeking a Quality Engineer with expertise in ISO 13485 and medical device manufacturing experience. The ideal candidate will have experience ensuring compliance with ISO 13485 standards, managing CAPA systems, and driving continuous improvement in a regulated environment.
Key Responsibilities:
- Ensure compliance with ISO 13485 and FDA regulations across the product lifecycle.
- Lead CAPA investigations, root cause analysis, and implementation of corrective/preventive actions.
- Assist in developing, maintaining, and auditing the Quality Management System (QMS).
- Support risk management activities and supplier quality management.
- Provide training on quality standards and continuous improvement initiatives.
Qualifications:
- Bachelor’s degree in Engineering or related field.
- years of experience in quality engineering, specifically with ISO 13485 and CAPA.
- Strong knowledge of ISO 13485, FDA 21 CFR 820, and risk management methodologies.
- Excellent problem-solving, communication, and organizational skills.
- Proficient in Microsoft Office and quality management software.