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Regulatory Compliance Expert

1 week ago

Pasir Gudang, Johor, Malaysia Masimo Full time

Masimo is looking for a Regulatory Compliance Expert to ensure our quality management systems meet industry standards and regulations.

The ideal candidate will develop, implement, and maintain an effective Quality Management System in compliance with industry standards (e.g., ISO 9001, ISO 13485). This role involves staying informed about changes in regulations and standards affecting the industry and implementing necessary updates to the QMS.

  • Compliance with Industry Standards: Ensure the organization complies with all relevant quality and regulatory standards.
  • QMS Development and Implementation: Develop, implement, and maintain an effective Quality Management System that meets relevant industry standards.
  • Root Cause Analysis and Corrective Actions: Conduct root cause analysis and implement corrective and preventive actions to address nonconformities.
  • SUPPLIER QUALITY MANAGEMENT: Collaborate with suppliers to ensure the quality of incoming materials and components.

This role requires strong analytical and problem-solving skills, excellent communication and interpersonal skills, and knowledge of relevant quality standards and regulations.