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Quality Management System Specialist - Venlo - Stryker Corporation

Date de publication : 4/2/2019

Résumé de l'offre

Description de l'offre

Your key Responsibilities

The Quality Management System Specialist will work within the Quality Management System (QMS) team, under minimal supervision, with responsibility to ensure an effective and efficient quality management system is built and maintained, which includes, but not limited to the following:

  • Ensure the Quality Management System is in compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, EU MDR, and individual country regulatory requirements)
  • Drive development and/or modification of Stryker's regional/local Quality Management Systems.
  • Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
  • Contribute to the development, maintenance and improvements of the policies and procedures.
  • Implement best in class QS practices and benchmark against industry leads and regulatory requirements.
  • In a project environment, lead and execute development and/or modification of Stryker's regional/local Quality Management Systems.
  • Co-ordinate all QA activities to ensure project milestones of assigned projects are met in accordance with QS development.
  • Strong knowledge of the system integrations.

What are we looking for?

  • Bachelor/Master degree in Engineering or equivalent/related subject required, or
  • Technician degree with 8 years of experience in a quality discipline
  • Minimum of 2 years in Quality Management Systems, minimum of 4 years in Quality/Regulatory Affairs environment
  • Thorough knowledge and understanding of US and International Medical Device Regulations as well as of European and international regulatory/industry guidelines/standards
  • Strong knowledge of Quality Systems (e.​g.​ CA​PA, Audits, Management review, Quality Planning).
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
  • Strong in critical thinking and "outside the box" thinking as well as highly developed problem solving skills.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently

Work From Home: No

Travel Percentage: Up to 25%

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