QA/QC Engineer I

The Quality Assurance Engineer I supports quality assurance and product development activities in accordance with medical device regulations, including 21 CFR 820, the Medical Device Directive (MDD), ISO 13485, and ISO 14971. Under the guidance of senior QA staff, the engineer assists with incoming inspection and product release tasks by following established procedures to help ensure products meet defined specifications and quality requirements. The duties will also include providing support for document control activities, helping maintain quality records, assisting with CAPA documentation, and participating in basic product review investigations as assigned. The QA Engineer I also works with Product Development by completing required design control documentation and following...