Specialist I – Q&R-QA/QE, EDI Q&R Process QA &QE 626 views

Job Description

  • 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

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