Senior Quality Auditor
St Petersberg/Tampa, FL
Sr. Quality Auditor (ISO 13485)
Summary: Our client is a leading maker of medical devices and supplies as well as surgical products. Currently looking for a quality auditor. To perform an independent MDSAP/ISO 13485 gap assessment of their current processes.
Responsibilities: The auditor will have to have had experience conducting ISO 13485 audits and will be well-versed in all current FDA rules and regulations as it pertains to ISO 13485: 2016. They will be a quality auditor, with very heavy experience in the medical device industry. They need to be able to manage themselves and have experience with comprehensive quality audits and to provide a detailed follow-up Audit Report at the conclusion of the audit.
· Quality Auditing: 8-10 years
· Medical Device: 8-10 years
· ISO 13485: 2016 certified