Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, Product risk management, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.
Accountable for oversight of quality and risk management throughout the product lifecycle
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
Experience in working with legal documents
Knowledge of external regulations and standards relevant for our products
Ability to translate legal requirements in to procedures and instructions