JOB DESCRIPTION:

The global center of Software Development for Envista, Medicim, located in Mechelen, is world leader in innovative software solutions for the dental profession. We investigate, develop, maintain, and support innovative software solutions for clinicians and dental technicians. Our software solutions create intuitive workflows for image acquisition, diagnostics, treatment planning, prosthetic CAD/CAM, and dental team collaboration to treat patients better. DTX Studio is our flagship software suite. We want to shape the innovation and the industry.

We are looking for QA/RA Officer to join the Quality Assurance and Regulatory Affairs team.

The QA/RA Officer will:

• Support QA/RA with the maintenance of the Quality Management System documentation to ensure compliance applicable medical device regulations.
• Provide administrative support for notifications and submissions.
• Review of records as document controller.
• Maintain training documentation and ensure timeliness of training.
• CAPA management, support with root cause investigation and administrative support in CAPA’s.
• Assist with internal and external audits.

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JOB REQUIREMENTS:

• Bachelor’s degree or higher
• Experience in Medical Device or other regulated industry
• Experience in Quality Assurance or Regulatory Affairs
• Fluent in English, good oral and written communication skills
• Pragmatic problem solver with attention to detail and completeness.
• Proactive work ethic.

Please refer the Job description for details