Contract position: A QA Engineer is needed for a leader in electronics, healthcare and lighting in the Wallingford, CT area. This position is responsible for receiving initial Change Order requests for new/revised controlled documents. No per diem available. No travel anticipated. Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Responsible for the maintenance and integrity of the Device Master Record, Design History File, Device History record and Quality System documentation.
- Review and process Engineering Change Requests (ECR) with accuracy and maintain product configuration within SAP.
- Knowledge of ISO and QSR requirements. Prefer at least 3 years experience in the medical device industry.
- Preferred experience in FDA Quality System820.40 and ISO 13485 requirements for Document Control.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.