Job Description Summary

Position Summary
Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.

Educational Background
Bachelor's degree in mechanical engineering, biomedical engineering or related engineering discipline.

Professional Experience
0-5 years of relevant experience

Job Description

Knowledge and Skills

a. Knowledge

• Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).