What are the responsibilities and job description for the Quality Engineer position at Management Recruiters of Tallahassee?
Job Description
Job Description
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 :