Back to jobs
Job Description
The Quality Assurance Engineer has the responsibilities to coordinate and perform quality assurance and product development activities according to medical device regulations of 21 CFR 820 and/or ISO 13485:2016, Medical Device Directive (MDD), ISO 13485, and ISO 14971. QA Engineer will be responsible for managing incoming inspection and product release activities. This includes ensuring incoming and final release products meet specifications and QA requirements. The duties will also include document control management, management of CAPA activities, product review investigations. QA Engineer will work with Product Development to ensure that design control process is followed for new and existing product lines.