What are the responsibilities and job description for the Quality Systems Engineer position at Rchling Medical Rochester?
Essential Duties / Responsibilities :
- Leads the effective development, implementation and continuous improvement of the organizations' quality assurance policies, assuring compliance with medical device standards (ISO 13485)
- Analyzes quality data and metrics to identify trends and areas for improvement.
- Create and maintain documentation related to quality processes, policies, reference procedures and work instructions in compliance with ISO 13485 and the FDA's Quality System Regulations
- Supports internal, customer and regulatory audits as required.
- Trains internal staff on quality procedures and best practices.
- Supports eQMS implementation projects for CAPA, document and record control.
- Additional support for the Quality Management System activities as assigned.
