Job Summary
The Quality Engineer plays a crucial role in assessing design outputs, upholding the Quality Management System, and overseeing risk assessment processes. This position also involves the qualification of suppliers, updating Corrective and Preventive Actions (CAPA), and ensuring adherence to regulatory requirements throughout the product development cycle.
Responsibilities
- Evaluate design outputs to ensure quality standards are met.
- Maintain and enhance the Quality Management System.
- Conduct risk assessments effectively.
- Manage the qualification of suppliers to ensure compliance.
- Update CAPA processes as necessary.
- Ensure regulatory compliance during product development activities.
Qualifications
- Bachelor’s degree in Mechanical Engineering or a related field.
- 2-5 years of experience working within a Medical Device Quality Management System.
- Strong understanding of ISO 13485, 21 CFR Part 820, and ISO 14971.
- Able to thrive in a manufacturing environment.
