Description
Daily tasks:Performing internal audits according 21 CFR 820; ISO EN 13485:2016; MDD; other applicable regulations
Writing quality reports and creating relevant documentation needed to support the successful audit
Follow up of internal and external audit observation to assure appropriate and timely implementation of Corrective Actions
Provide Regulatory Compliance support in all areas of Quality System Elements
Documentation review in Quality System relevant areas
PROFESSIONAL EXPERIENCE REQUIREMENTS:
* Master's degree in a technical or scientific discipline
* Proven exceptional written and oral presentation skills
* Working knowledge of applicable regulations.
* Experience in Medical Device regulated environment
OTHER REQUIREMENTS:
* Strong knowledge and skills in MS Office
* Excellent problem solving, decision-making, and root cause analysis skills are required.
* Interpersonal skills that foster conflict resolution are required.
* Ability to multi-task independently with minimal supervision
Minimum Language required
Michael Bailey International is acting as an Employment Business in relation to this vacancy.