- In this role, you have the opportunity to
- Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.
- Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.
- Review and Approval of designated project documentation in product creation projects.
- Advice to product creation projects concerning the definition and implementation of quality assurance activities
- Advise upper management with respect to release for delivery of products
- Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
- Initiate, stimulate, and support the implementation of process improvements
- Execution of audits in all business processes and report the findings to upper management
- Support and advise the organization in corrective and preventive actions
- Participate in the maintenance, improvement and deployment of the Quality Management System
- Translates regulations and standards and bring them to consolidation in the organization and the Quality Management System
- Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals
- Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.
Qualifications and Know-How
- Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science , electronics, Electrical or information technology.
- Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD, FDA-QSR)
- Knowledge of (software) processes and procedures
- Qualified Auditor of Quality Systems ( Preferable)
- Good skills in reporting, both in writing and oral
- Fluent speaker and writer in English
- Project management knowledge and skills.
- Sound knowledge of the basic functionality of our products
- Knowledge of product creation and (software) development methods & tools
- Experience in using problem solving tools
- Knowledge of external regulations and standards relevant for our products
- Ability to translate legal requirements in to procedures and instructions
- total experience of around 7 to 8 years with at lest 2 to 3 years in medical device industry
The Quality & Regulatory group is responsible for:
- Quality assurance and Quality Engineering aspects of product development
- Assessment of the quality performances and compliance of the organization
- The relation with external regulatory bodies
- Supporting the continuous improvement of processes and the initiation, maintenance and certification of the Quality Management System (QMS), while assuring regulatory compliance of this QMS