Description
Urgent Quality Documentation Senior Specialist (Medical Devices - Nord Switzerland)With quality products within the Medical Device industry my client is one of the market leaders in the industry.
The open position is a Quality Documentation Senior Specialist
The Job Holder coordinates all aspects of the document control and labeling, e.g. development, control, review, revision, distribution, publishing and retention. Internal customer focus is essential in completing multiple goals as established by multiple departments during the procedure development, review and approval process. This positions primary focus is to ensure all documents fully explain the associated processes, including any critical process parameters, and that the appropriate linkages have been established between related documents. Supporting all aspects of the business units as required. Is responsible for the training process and LMS, is acting as a CAPA Owner and project leader.
General Functions
- Principally responsible for the Document Management System and Archiving System
- Supports document control and the development of documents
- Responsible for compliance to all applicable procedures, ISO 13485 standard and the Quality System Regulations
- Creates and maintains new procedures
- Evaluate processes, creates/revises procedures and work instructions to ensure these processes are correctly documented
- Questions and coordinates responses in regard to procedure(s) status
- Distributes and manages process related documentation
- Ensures approved standard format which is used for all procedures
- Involved with label data management and designing and the layout of labels
- Maintains multiple reports, tables and various databases
- Serves as a checkpoint to ensure procedures are written in an understandable fashion
- Assists in strength / weakness analysis of the Quality Management System
- Lead projects
- Has knowledge in CAPA
- Assists in the development, implementation, and maintenance of electronic workflows
- Organizes trainings
Education
- Degree in business or engineering or professional experience in a similar position
- Past experience in procedure writing
- Past experience in supporting multiple customers
- Strong oral and written communications abilities in German and advanced English required.
- Ability to train personnel
- Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel, databases and SAP Knowledge
- Knowledge of applicable ISO Standards and general knowledge of US Quality System Regulations
If a challenging and varied career in an international environment, a market-based compensation package and modern working conditions sounds like a good opportunity for you, please apply today!
If this role, or other roles in this area, are of interest to you, send your CV directly to Lara Preite, at You can also call me on for a discussion on this, and any other vacancy. I am a recruitment consultant specialized in Quality assurance within the Medical Device industry.
<p>To find out more about Real please visit <a href="http://www.realstaffing.com">www.realstaffing.com</a></p>