Key Job Purpose:
The Quality Management (QM) Specialist is to support the QMR in ensuring the organization and its affiliates adhere to all applicable local, regulatory and quality standards associated with Enterprise Risk Management. As Subject Matter Expert (SME) for Enterprise Risks per ISO31000 and other ISO Standards for QMS, such as ISO13485, ISO14971, ISO27001, ISO14001 and WSH regulations.
The role serves to maintain a high standard of compliance, effectiveness, and continuous improvement throughout the organization's identified risks. The role will coordinate with Process Owners and appointed Risk Management PICs in Affiliates, monitor identified risks are managed in an effectiveness and timely manner. Report the progress of Enterprise Risks to Risk Management Committee in a biyearly manner.
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Summary of Functional Duties & Responsibilities:
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1.
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Risk Management:
- Coordinate and work with Process Owners to address and manage the identified risks, including the execution of their effective controls.
- Ensure effectiveness of risk control measures are executed by Process Owners where documented evidence indicated in the Risk Register are available and uploaded.
- Follow-up with QMR and relevant HODs on new processes or products or business model which may an impact to operational and governance processes.
- Analyse and do trending of enterprise risks within SAP and across the region which requires escalation or proposed sources of improvement to QMR. .
- Support QMR in coordinating the Risk Management Committee meeting at SAP in biyearly manner. Assist to prepare updates and follow up actions from the Risk Management Committee meeting.
- Extend consistent practices of Enterprise Risk Management to Affiliates.
SME for Risk Management and provide training on Risk Managements to SAP and affiliates.
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2.
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Audit Support (Internal and external):
- Assist in the planning, execution, and follow-up of internal audits, ensuring compliance with regulatory standards and company policies.
- Support external audits by coordinating audit activities, preparing documentation, and ensuring audit readiness associated with Enterprise Risks
- Ensure that audit findings associated with Enterprise Risks are addressed through effective corrective actions and continuous improvement.
- Perform analysis trending on Corporate Audit findings for all affiliates in SAP and share result to QMR for reporting to Top Management.
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3.
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Environmental & WSH Support
- Support in coordinating with relevant stakeholders and assessing the impact of environmental / WSH information to the organization.
- Identify environmental issues that impact the organization, associated risks are included in Legal Risk Register and control measures are effectively put in place.
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- Relevant Diploma / Degree
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Min. 2 years experience in Quality Assurance role in Medical Devices industry
Certified Internal Auditor for ISO13485 / ISO9001, ISO 31000 and/or ISO14001
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ISO 13485 / ISO 9001 ISO 27001.
ISO 14001 Environmental Management Systems (EMS)
ISO 31000 Risk management
Workplace Safety and Health
Microsoft Office
Previous experience in Risk Management Activities, Data Trending & Analysis.
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