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Quality System Manager

2 weeks ago

Pasir Gudang, Johor, Malaysia Masimo Full time

At Masimo, we are seeking a highly skilled Quality System Manager to enhance product quality and improve processes.

The ideal candidate will be responsible for developing, implementing, and maintaining an effective Quality Management System in compliance with industry standards and regulations. This role plays a key part in ensuring organizational compliance and driving continuous improvement initiatives.

  • Developing and Implementing QMS: Develop, implement, and maintain an effective Quality Management System that meets relevant industry standards (e.g., ISO 9001, ISO 13485).
  • Compliance and Risk Management: Ensure the organization complies with all relevant quality and regulatory standards. Stay informed about changes in regulations and standards affecting the industry and implement necessary updates to the QMS.
  • Process Enhancement and Improvement: Identify opportunities for process improvements and collaborate with cross-functional teams to implement changes. Conduct root cause analysis and implement corrective and preventive actions.
  • Documentation Oversight: Oversee the creation, revision, and maintenance of quality documentation, including procedures, work instructions, and records.
  • Audits and Inspections Support: Plan and conduct internal and external audits to assess compliance with quality standards. Prepare for and support regulatory inspections as needed.

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